JTH LabVerify AI — FDA CLIA Record Lookup Research Beta

RESEARCH BETA — NOT INDEPENDENTLY CLINICALLY OR REGULATORILY VALIDATED

JTH LabVerify AI retrieves publicly available FDA CLIA categorization information for research and informational purposes. It does not independently determine test complexity, establish laboratory authorization, provide clinical advice, or replace official FDA/CMS guidance, manufacturer instructions, or qualified regulatory judgment.

J T Hunt Enterprises LLC is not affiliated with or endorsed by the FDA or CMS.

Users must verify current official records before making laboratory, clinical, or compliance decisions.

Scope

Retrieve source-attributed FDA CLIA categorization records for laboratory test classification research and laboratory regulatory data workflows. Only lookup is enabled. Crosswalk, change-sentinel, clinical decisions, and laboratory authorization determinations are unavailable. Do not submit patient information, PHI, credentials, or private records.

Source and freshness

Source: https://www.accessdata.fda.gov/premarket/ftparea/clia_detail.zip

FDA field documentation: https://www.fda.gov/medical-devices/medical-device-databases/clinical-laboratory-improvement-amendments-download-data

Official record search: https://www.accessdata.fda.gov/Scripts/cdrh/cfdocs/cfClia/search.cfm

The Actor downloads the official archive on each run but accepts only the pinned, technically checked archive. It is not an unrestricted live-update service. The accepted archive was last modified October 26, 2026 at 09:10:03 UTC and was checked again October 30, 2026 at 08:25:03 UTC. It contains 81,155 records. SHA-256: b3d15060739adb72487a3dc772c6fae3fcd63ce14222535cc199983044d0bc54.

Five reference records matched all ten source fields and 39 source tests passed. These targeted checks do not constitute comprehensive validation of the FDA database or independent clinical/regulatory validation. Download failure, changed hash, invalid structure, unknown categories, or failed reference checks stop the run without emitting results. A changed source requires review and retesting before acceptance.

Input

{
  "operation": "lookup",
  "queries": [{
    "documentNumber": "CR200192",
    "testSystemName": "Abbott Diagnostics Scarborough Inc., BinaxNOW Strep A Card",
    "analyteName": "Streptococcus, group A",
    "qualifier": "Direct from Throat Swabs"
  }],
  "maxCandidates": 10
}

Supply 1–20 queries. Each identifier must be a string no longer than 512 characters. At least a document number, test-system name, or analyte is required. maxCandidates is an integer from 1 to 50, default 10. Unknown fields and other operations are rejected before downloading. Matching is case-insensitive with whitespace normalization; punctuation is preserved. Broad queries return candidates, not a classification decision.

Output interpretation

Status	Meaning
exact_record_found	One source row matches document, system, analyte and applicable qualifier. reported_complexity repeats FDA's field; it is not an independent determination.
ambiguous_or_incomplete	Multiple rows or incomplete identifiers; no preferred classification or reported_complexity.
qualifier_review_required	A matching row has a qualifier that was not supplied; no reported_complexity.
no_exact_match	No row matches the supplied filters. This does not mean a product lacks clearance or a laboratory is unauthorized.

Each result includes query, candidates with FDA fields and source attribution, total_exact_filter_hits, truncated, source metadata and a limitation notice. date_effective is FDA's categorization date, not the fetch date. Check http_last_modified, checked_at_utc, and the archive hash for provenance. If truncated is true, increase maxCandidates up to 50 or narrow the query; never treat the displayed subset as complete or ranked.

K960712 / BinaxNOW Strep A Card / Streptococcus, group A / direct from throat swab has both MODERATE and WAIVED rows in the accepted archive. Both are preserved, with ambiguous status and no selected classification. Seek official clarification rather than assuming one supersedes the other.

The output schema links to the run's dataset. Confirm the run succeeded before using its output. The following non-sensitive example is from the private cloud regression, not a new clinical interpretation.

{
  "status": "ambiguous_or_incomplete",
  "query": {
    "document_number": "K960712",
    "test_system_name": "BinaxNOW Strep A Card",
    "analyte_name": "Streptococcus, group A",
    "qualifier": "direct from throat swab"
  },
  "total_exact_filter_hits": 2,
  "candidates": [
    {
      "document_number": "K960712",
      "test_system_id": "21324",
      "test_system_name": "BinaxNOW Strep A Card",
      "qualifier1": "",
      "qualifier2": "direct from throat swab",
      "analyte_id": "104",
      "analyte_name": "Streptococcus, group A",
      "specialty_id": "8",
      "complexity": "MODERATE",
      "date_effective": "2013/01/16 00:00:00.000",
      "specialty_name": "Bacteriology",
      "source_database": "https://www.accessdata.fda.gov/Scripts/cdrh/cfdocs/cfClia/search.cfm"
    },
    {
      "document_number": "K960712",
      "test_system_id": "21324",
      "test_system_name": "BinaxNOW Strep A Card",
      "qualifier1": "",
      "qualifier2": "direct from throat swab",
      "analyte_id": "104",
      "analyte_name": "Streptococcus, group A",
      "specialty_id": "8",
      "complexity": "WAIVED",
      "date_effective": "2013/01/16 00:00:00.000",
      "specialty_name": "Bacteriology",
      "source_database": "https://www.accessdata.fda.gov/Scripts/cdrh/cfdocs/cfClia/search.cfm"
    }
  ],
  "truncated": false,
  "source": {
    "source": "https://www.accessdata.fda.gov/premarket/ftparea/clia_detail.zip",
    "archive_sha256": "b3d15060739adb72487a3dc772c6fae3fcd63ce14222535cc199983044d0bc54",
    "http_last_modified": "Mon, 26 Oct 2026 09:10:03 GMT",
    "record_count": 81155,
    "source_type": "official_fda_download",
    "structural_validation": {
      "structure_check_passed": true,
      "record_count": 81155,
      "complexity_counts": {
        "moderate": 47442,
        "waived": 21893,
        "high": 11820
      },
      "archive_sha256": "b3d15060739adb72487a3dc772c6fae3fcd63ce14222535cc199983044d0bc54",
      "limitation": "Structural integrity only; complete regulatory record accuracy not verified."
    },
    "checked_at_utc": "2026-10-30T06:22:36.562270+00:00",
    "reviewed_archive_match": true,
    "five_record_checks_passed": true
  },
  "notice": "A record match is not a determination of laboratory authorization, current marketing status, specimen configuration or compliance. Verify applicable manufacturer instructions and FDA/CMS sources."
}

Pricing and limits

Intended beta model: Apify pay per usage with no additional JTH developer fee. Apify platform compute/storage/data usage may consume the user's included allowance or be billed under that user's plan. No JTH pay-per-event charge, subscription, external AI call, paid proxy, or Standby capability is provided. Do not describe this as unlimited or universally cost-free.

Limitations and review

No professional review approval, certification, FDA/CMS endorsement, clinical validation, or compliance guarantee is claimed. Records may be historical or ambiguous; absence of a match is inconclusive. Verify current official records, exact configuration, manufacturer instructions, and applicable FDA/CMS requirements before decisions. Voluntary external courtesy review and FDA clarification remain outstanding; findings will be assessed through controlled updates and retesting.

Documentation prepared October 30, 2026 by J T Hunt Enterprises LLC. Publication status must be verified separately.