Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KXS — Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
41 daysmedian FDA review time
113 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011164 | MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL O | Syva Co., Dade Behring, Inc. | 2001-05-10 | 24 | 0 |
| K993986 | SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL | Syva Co. | 2000-01-27 | 64 | 0 |
| K955676 | SYNCHRON SYSTEMS METHAQUALONE REAGENT | Beckman Instruments, Inc. | 1996-03-04 | 80 | 0 |
| K945187 | ROCHE ABUSCREEN ONLINE FOR METHAQUALONE | Roche Diagnostic Systems, Inc. | 1995-04-05 | 163 | 0 |
| K940123 | METHAQUALONE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1994-05-03 | 113 | 0 |
| K921013 | SYVA EMIT II METHAQUALONE ASSAY | Syva Co. | 1992-05-13 | 71 | 0 |
| K874272 | REVISED LABELING FOR METHAQUALONE TEST KIT | Roche Diagnostic Systems, Inc. | 1987-11-13 | 24 | 0 |
| K874199 | REVISED LABELING FOR SYVA METHAQUALONE ASSAYS | Syva Co. | 1987-10-28 | 14 | 0 |
| K873759 | LABELING CHANGE COAT-A-COUNT METHAQUALONE | Diagnostic Products Corp. | 1987-10-15 | 41 | 0 |
| K870935 | COAT-A-COUNT METHAQUALONE TKMQ1 | Diagnostic Products Corp. | 1987-03-19 | 10 | 0 |
| K843605 | EMIT 700 METHAQUALONE ASSAY | Syva Co. | 1984-10-05 | 22 | 0 |
| K840164 | EMIT ST URINE METHAQUALONE ASSAY | Syva Co. | 1984-03-22 | 66 | 0 |
| K830461 | ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE | Hoffmann-La Roche, Inc. | 1983-03-24 | 37 | 0 |
| K822051 | EMIT D.A.V. METHAQUALONE ASSAY | Syva Co. | 1982-07-27 | 14 | 0 |
| K821768 | EMIT ST URINE METHAGUALONE ASSAY | Syva Co. | 1982-06-24 | 9 | 0 |
| K812987 | AGGLUTEX METHAQUALONE TEST KIT | Hoffmann-La Roche, Inc. | 1981-12-22 | 57 | 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