Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advantage Diagnostics Corp. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
116 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023712 | ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST | Advantage Diagnostics Corp. | 2003-01-31 | 88 | 0 |
| K013778 | PEACE OF MIND HOME DRUG TEST | Advantage Diagnostics Corp. | 2002-02-07 | 86 | 0 |
| K011962 | ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST | Advantage Diagnostics Corp. | 2001-08-09 | 48 | 0 |
| K010921 | ADVANTAGE MARIJUANA (THC) HOME DRUG TEST | Advantage Diagnostics Corp. | 2001-06-25 | 90 | 0 |
| K003708 | ADVANTAGE THC/COCAINE TEST | Advantage Diagnostics Corp. | 2001-01-22 | 52 | 0 |
| K001567 | ADVANTAGE THC TEST | Advantage Diagnostics Corp. | 2000-06-19 | 31 | 0 |
| K994227 | ADVANTAGE HCG TEST (URINE/SERUM) | Advantage Diagnostics Corp. | 2000-02-03 | 50 | 0 |
| K991883 | REDI-TEST OPIATES | Advantage Diagnostics Corp. | 1999-09-15 | 105 | 0 |
| K903416 | CANNULA, SURGICAL | Advantage Diagnostics Corp. | 1990-11-23 | 116 | 0 |
| K881369 | ADVANCE DIAGNOSTICS DISPOSABLE EYECUP | Advantage Diagnostics Corp. | 1988-05-13 | 42 | 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