510(k) Report

510(k) · Cleared

Cleared

Synchron Systems Methaqualone Reagent

K955676510(k) TraditionalCleared Mar 4, 199680-day reviewClass II21 CFR 862.3630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Beckman Instruments, Inc. · KXS Radioimmunoassay, Methaqualone

Cleared on Mar 4, 1996 as substantially equivalent to K921013 (Syva Co., 1992) and 2 other predicates after an 80-day review. Its family tree reaches back 1 generation to 1992.

Decided
Mar 4, 1996
Review
80 days
Class
Class II
Product code
KXS
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K921013 (1992). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 2 other ancestorsK921013 · Syva Emit II Methaqualone Assay · Syva Co. · 199219901992199419961998
Other ancestors, by generation 1 generation back: 2 other ancestors K921013 · Syva Emit II Methaqualone Assay · Syva Co. · 19920
  1. Root · 1 generation backK921013 Syva Emit II Methaqualone AssaySyva Co. · 1992
  2. This deviceK955676 Synchron Systems Methaqualone ReagentBeckman Instruments, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K921013Syva Emit II Methaqualone AssaySyva Co.1992—
0 (this device)K955676Synchron Systems Methaqualone ReagentBeckman Instruments, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
FIG. 1 — Lineage of K955676, 1992–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KXS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K921013Syva Emit II Methaqualone Assay
Summary page 1
…t system (21 CFR 862.3630) Toxicology calibrator (21 CFR 862.3200) Toxicology control (21 CFR 862.3280) 4.0 Predicate Device(s) Emit Il Methaqualone Assay, Syva Company, K921013 Methaqualone Reagent, Diagnostic Reagents, Inc, K940123 Urine Calibrator and Controls, Diagnostic Reagents, Inc., K935101 5.0 Des…
Syva Co.1992—
*K940123Methaqualone Enzyme Immunoassay
Summary page 1
…862.3200) Toxicology control (21 CFR 862.3280) 4.0 Predicate Device(s) Emit Il Methaqualone Assay, Syva Company, K921013 Methaqualone Reagent, Diagnostic Reagents, Inc, K940123 Urine Calibrator and Controls, Diagnostic Reagents, Inc., K935101 5.0 Description The SYNCHRON Methaqualone Reagent is an enzyme…
Diagnostic Reagents, Inc.1994—
*K935101Urine Calibrators and Controls Modification
Summary page 1
…ce(s) Emit Il Methaqualone Assay, Syva Company, K921013 Methaqualone Reagent, Diagnostic Reagents, Inc, K940123 Urine Calibrator and Controls, Diagnostic Reagents, Inc., K935101 5.0 Description The SYNCHRON Methaqualone Reagent is an enzyme immunoassay reagent test kit for the SYNCHRON Systems and provides…
Diagnostic Reagents, Inc.1994—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.

How does its category compare?

All KXS devices

KXS Radioimmunoassay, Methaqualone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KXS

FDA has decided no KXS device since 2007.

Median 510(k) review, days · KXS

Too few KXS 510(k)s in any year since 2007 to give a median.

Recalls per year · KXS

No recall names KXS since 2007.

Adverse event reports per year · KXS

No MAUDE report names KXS since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The SYNCHRON Systems Methaqualone Reagent, in conjunction with the SYNCHRON System DAT Urine Calibrators, is intended for use in the qualitative determination of Methaqualone in human urine samples. This assay is designed for use with the family of SYNCHRON Systems, which include analyzers such as the SYNCHRON CX®4, CX®4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Beckman Instruments, Inc.

281 FDA decisions under this applicant name. See the company

  • K973448Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465, 34469Beckman Instruments, Inc. · 1998
  • K982250Access Free T4 Reagents on the Access Immunoassay AnalyzerBeckman Instruments, Inc. · 19984 recalls
  • K981403Immage Immunochemistry System Valproic Acid (Vpa) ReagentBeckman Instruments, Inc. · 1998
  • K981354Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211Beckman Instruments, Inc. · 19981 recall
  • K980173Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505Beckman Instruments, Inc. · 19981 recall

Recent decisions in KXS

The KXS category page

  • K011164Modification to the Emit II Plus Methaqualone Assay, Model OSR9Q229Syva Co., Dade Behring, Inc. · 2001
  • K993986Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULSyva Co. · 2000
  • K945187Roche Abuscreen Online for MethaqualoneRoche Diagnostic Systems, Inc. · 1995
  • K940123Methaqualone Enzyme ImmunoassayDiagnostic Reagents, Inc. · 1994
  • K921013Syva Emit II Methaqualone AssaySyva Co. · 1992

https://510kreport.com/device/K955676 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955676: Synchron Systems Methaqualone Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955676

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026