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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Tcpi, Inc. — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

119 daysmedian FDA review time
422 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K981363ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TESTTcpi, Inc.1998-12-222510
K972960HEALTH CHECK URI-TEST PROTEIN IN URINETcpi, Inc.1998-10-074220
K981197ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TESTTcpi, Inc.1998-06-16750
K980776ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TESTTcpi, Inc.1998-04-29580
K951853ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)Tcpi, Inc.1996-08-204870
K954968HEALTH CHECK URI-TEST GLUCOSE IN URINE TESTTcpi, Inc.1996-07-262730
K954685URITEST - NITRITE IN URINE TESTTcpi, Inc.1996-07-222850
K955353ONE STEP PREGNANCY HCG SERUN DILUENT REAGENTTcpi, Inc.1996-03-191190
K951892ONE STEP URINE DRUG OF ABUSE COCAINE TESTTcpi, Inc.1995-08-171150
K952096ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHTcpi, Inc.1995-08-171050
K941765HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USETcpi, Inc.1994-10-202090
K935134ONE STEP LH TESTTcpi, Inc.1994-01-11750
K934830HCG PREGNANCY ONE STEP TEST STRIPTcpi, Inc.1993-12-02550
K923123HCG PREGNANCY ONE STEP TEST STRIPTcpi, Inc.1992-09-09750

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda