510(k) Report

510(k) · Cleared

Cleared

Binax Strep a Test

K960712510(k) TraditionalCleared Mar 22, 199630-day reviewClass I21 CFR 866.3740

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

Binax, Inc. · GTZ Antisera, All Groups, Streptococcus Spp.

Cleared on Mar 22, 1996 as substantially equivalent to K934484 (Quidel Corp., 1994) and 2 other predicates after a 30-day review. Its family tree reaches back 1 generation to 1990.

Decided
Mar 22, 1996
Review
30 days
Class
Class I
Product code
GTZ
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K901274 (1990). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestor1992: 1 other ancestorK901274 · Testpack Plus Strep a · Abbott Laboratories · 199019901992199419961998
Other ancestors, by generation 1 generation back: 2 other ancestors K901274 · Testpack Plus Strep a · Abbott Laboratories · 19900
  1. Root · 1 generation backK901274 Testpack Plus Strep aAbbott Laboratories · 1990
  2. This deviceK960712 Binax Strep a TestBinax, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K901274Testpack Plus Strep aAbbott Laboratories1990—
0 (this device)K960712Binax Strep a TestBinax, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199410
FIG. 1 — Lineage of K960712, 1990–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 GTZ? 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
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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
*K934484Quickvue in-Line One-Step Strep a Test
Summary page 1
…ation name per Section 866.3740 is "Streptococcus Spp. Serological Reagents." . The device 1is substantially equivalent to Quidel QuickVue In-Line One-Step (510(k) no. K934484) and Abbott TestPack Plus (510(k) nos. K901274 & K922345) Strep A Tests. The Binax Strep A Test is an immunochromatographic memb…
Quidel Corp.1994—
*K901274Testpack Plus Strep a
Summary page 1
…us Spp. Serological Reagents." . The device 1is substantially equivalent to Quidel QuickVue In-Line One-Step (510(k) no. K934484) and Abbott TestPack Plus (510(k) nos. K901274 & K922345) Strep A Tests. The Binax Strep A Test is an immunochromatographic membrane assay to detect Streptococcus pyogenes Gro…
Abbott Laboratories1990—
*K922345Testpack Plus Strep a
Summary page 1
…rological Reagents." . The device 1is substantially equivalent to Quidel QuickVue In-Line One-Step (510(k) no. K934484) and Abbott TestPack Plus (510(k) nos. K901274 & K922345) Strep A Tests. The Binax Strep A Test is an immunochromatographic membrane assay to detect Streptococcus pyogenes Group A antig…
Abbott Laboratories1992—

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 GTZ devices

GTZ Antisera, All Groups, Streptococcus Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GTZ

FDA has decided no GTZ device since 2007.

Median 510(k) review, days · GTZ

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

Recalls per year · GTZ

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GTZ

10in 2025

2011: 22013: 12016: 12017: 22018: 82019: 12024: 42025: 10
2007high 10 (2025) · low 0 (2007)2025

MAUDE reports naming product code GTZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—10
20100—00
20110—02
20120—00
20130—01
20140—00
20150—00
20160—01
20170—02
20180—08
20190—01
20200—00
20210—00
20220—00
20230—00
20240—04
20250—010
20260—0—

What is it indicated for?

The Binax Strep A Test is intended for in vitro diagnostic use in clinical and physician office laboratories to qualitatively detect the presence of Streptococcus pyogenes Group A antigen from throat swabs.

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

More from Binax, Inc.

30 FDA decisions under this applicant name. See the company

  • K090301Binaxnow PBP2A Test, Model 890-000Binax, Inc. · 2010
  • K091766Clearview Exact PBP2A Test, Model 891-000Binax, Inc. · 2010
  • K090964Binaxnox Staphylococcus Aureus TestBinax, Inc. · 2009
  • K091489Clearview Advanced Strep a , Model 737-430Binax, Inc. · 2009
  • K083744Binaxnow Malaria Positive Control Kit, Model 665-010Binax, Inc. · 2009

Recent decisions in GTZ

The GTZ category page

  • K012521Binax Now Streptococcus Pneumoniae TestBinax, Inc. · 20011 recall
  • K011709Uni-Gold Strep a Test KitTrinity Biotech, Plc · 2001
  • K010523Modification to Binax Now Streptococcus Pneumoniae Urinary Antigen TestBinax, Inc. · 2001
  • K991726Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test Kit),(12 Test Kit), Binax Nowr…Binax, Inc. · 1999
  • K971522Abbott Testpack Plus Strep a with on Board Controls (Obc) IIAbbott Laboratories · 19981 recall

https://510kreport.com/device/K960712 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960712: Binax Strep a Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960712

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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