510(k) Report

510(k) · Cleared

Cleared

Abbott Strep a Controls

K972182510(k) TraditionalCleared Aug 13, 199776-day reviewClass I21 CFR 862.1660

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

Abbott Diagnostics · MJZ Kit, Direct Antigen, Positive Control

Cleared on Aug 13, 1997 as substantially equivalent to K922490 (Abbott Laboratories, 1992) after a 76-day review. Its family tree reaches back 1 generation to 1992.

Decided
Aug 13, 1997
Review
76 days
Class
Class I
Product code
MJZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K922490 (1992). No later device cites it as a predicate yet.

K922490 · Abbott Strep a Controls · Abbott Laboratories · 199219901992199419961998
K922490 · Abbott Strep a Controls · Abbott Laboratories · 19920
  1. Root · 1 generation backK922490 Abbott Strep a ControlsAbbott Laboratories · 1992
  2. This deviceK972182 Abbott Strep a ControlsAbbott Diagnostics · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K922490Abbott Strep a ControlsAbbott Laboratories1992—
0 (this device)K972182Abbott Strep a ControlsAbbott Diagnostics1997—
FIG. 1 — Lineage of K972182, 1992–1997Source: 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.

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  • 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? (1)

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
*K922490Abbott Strep a Controls
Summary page 1
…tes data supporting a substantially equivalent determination. Substantial equivalence has been demonstrated between Abbott STREP A Controls and Abbott STREP A Controls, K922490. The Abbott STREP A Controls, K965252 is the same as Abbott STREP A Controls, K922490. The controls are intended for use as exte…
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?

  • Its one ancestor has no recall.

How does its category compare?

All MJZ devices

MJZ Kit, Direct Antigen, Positive Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MJZ

1in 2009

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

2026 to Oct 25, outlined.

Median 510(k) review, days · MJZ

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

Recalls per year · MJZ

No recall names MJZ since 2007.

Adverse event reports per year · MJZ

No MAUDE report names MJZ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—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?

Abbott STREP A Controls are qualitative control materials intended for use in test systems to monitor substantial reagent failure and procedural errors. Specifically,

Abbott STREP A Controls are intended for use as external controls in Abbott Rapid Immunoassays for the qualitative detection of Group A Streptococcal antigen.

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

More from Abbott Diagnostics

28 FDA decisions under this applicant name. See the company

  • K964185IMX CA 125Abbott Diagnostics · 19974 recalls
  • K961439Abbott Cell-Dyn 4000 SystemAbbott Diagnostics · 19967 recalls
  • K890491Cell-Dyn 3000 Multi-Parameter Hematology AnalyerAbbott Diagnostics · 19891 recall
  • K881242Cell-Dyn Rapid-Lyse and HemogloblinAbbott Diagnostics · 1988
  • K881130Cell-Dyn Isotonic DiluentAbbott Diagnostics · 1988

Recent decisions in MJZ

The MJZ category page

  • K083744Binaxnow Malaria Positive Control Kit, Model 665-010Binax, Inc. · 2009
  • K972129Chlamydiatrol AGBlackhawk Biosystems, Inc. · 1997

https://510kreport.com/device/K972182 · printed Nov 5, 2026

Cite this page

510(k) Report. “K972182: Abbott Strep a Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972182

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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