510(k) Report

510(k) · Cleared

Cleared

EZ Detect, 5 Minute Strep-a Color Test

K860923510(k) TraditionalCleared May 16, 198666-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

Self Care Systems, Inc. · GTZ Antisera, All Groups, Streptococcus Spp.

Cleared on May 16, 1986 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 16, 1986
Review
66 days
Class
Class I
Product code
GTZ
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K860923Source: FDA 510(k) database · 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

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—

More from Self Care Systems, Inc.

3 FDA decisions under this applicant name. See the company

  • K854358EZ Detech-Urine Blood Test SticksSelf Care Systems, Inc. · 1986
  • K860028Modified EZ Detect Occult Blood Test in StoolSelf Care Systems, Inc. · 1986

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/K860923 · printed Nov 6, 2026

Cite this page

510(k) Report. “K860923: EZ Detect, 5 Minute Strep-a Color Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K860923

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026