Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LFG · Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
52 daysmedian FDA review time
190 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151348 | Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), | Healgen Scientific,, LLC | 2015-08-18 | 90 | 0 |
| K142609 | CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine | Guangzhou Wondfo Biotech Co., Ltd. | 2014-12-18 | 93 | 0 |
| K112395 | WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS U | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-09 | 21 | 0 |
| K072062 | UCP MULTIPLE DRUG SCREEN TEST CUPS | Ucp Biosciences, Inc. | 2007-09-20 | 55 | 0 |
| K061457 | UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPH | Ucp Biosciences, Inc. | 2006-08-21 | 88 | 0 |
| K021526 | ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DE | ACON Laboratories, Inc. | 2002-07-17 | 68 | 0 |
| K011545 | VERDICT -II TCA, VERDICT-II MTD | Medtox Diagnostics, Inc. | 2001-06-08 | 21 | 0 |
| K980249 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | Princeton BioMeditech Corp. | 1998-03-13 | 49 | 0 |
| K870823 | EMIT NORTRIPTYLINE ASSAY | Syva Co. | 1987-03-20 | 17 | 0 |
| K861155 | EMIT DESIPRAMINE ASSAY | Syva Co. | 1986-05-02 | 35 | 0 |
| K853113 | TD TRICYCLIC ANTIDEPRESSANTS | Abbott Laboratories | 1985-08-12 | 19 | 2 |
| K844950 | EMIT AMITRIPTYLINE ASSAY | Syva Co. | 1985-06-28 | 190 | 0 |
| K844951 | EMIT IMIPRAMINE ASSAY | Syva Co. | 1985-06-28 | 190 | 0 |
| K844952 | EMIT NORTRIPTYLINE ASSAY | Syva Co. | 1985-06-28 | 190 | 0 |
| K844953 | EMIT DESIPRAMINE ASSAY | Syva Co. | 1985-06-28 | 190 | 0 |
| K841532 | ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES | E.I. Dupont DE Nemours & Co., Inc. | 1984-05-02 | 16 | 0 |
| K834550 | EMIT ST SERUM TRICYCLIC ANTIDEPRESSANT | Syva Co. | 1984-03-19 | 83 | 0 |
| K831978 | EMIT SERUM TRICYCLIC ANTIDEPRESSENT | Syva Co. | 1983-08-11 | 52 | 0 |
| K821743 | EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY | Syva Co. | 1982-07-02 | 18 | 1 |
| K821652 | DOXEPIN TRI-CY TEST SET | Wien Laboratories, Inc. | 1982-06-14 | 11 | 0 |
| K821653 | PROTRIPTYLINE TRI-CY TEST SET | Wien Laboratories, Inc. | 1982-06-14 | 11 | 0 |
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