510(k) · Cleared

Recalled · 2003

Beckman Anti-Streptolysin O Kit

K926236510(k) TraditionalCleared Jun 15, 1993186-day reviewClass I21 CFR 866.3720Recalls 1

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

Beckman Instruments, Inc. · GTQ Antistreptolysin - Titer/Streptolysin O Reagent

Cleared on Jun 15, 1993 after a 186-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled once.

Decided: Jun 15, 1993
Review: 186 days
Class: Class I
Product code: GTQ
Recalls: 1
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK926236 Beckman Anti-Streptolysin O KitBeckman Instruments, Inc. · 1993
Descendant · cites it directly · 0 of its ownK071002 Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive…Beckman Coulter, Inc. · 2007
Descendant · cites it directly · 0 of its ownK971283 Synchron Systems Cal 5 PlusBeckman Instruments, Inc. · 1997

Most influential descendants

Showing 2 of 2 · See all

K071002Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (CCRP) ReagentBeckman Coulter, Inc. · 2007 · cites it directly0descendants
K971283Synchron Systems Cal 5 PlusBeckman Instruments, Inc. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K926236	Beckman Anti-Streptolysin O Kit	Beckman Instruments, Inc.	1993	—
+1	K071002	Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein…	Beckman Coulter, Inc.	2007	—
+1	K971283	Synchron Systems Cal 5 Plus	Beckman Instruments, Inc.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2007	1	0

FIG. 1 — Lineage of K926236, 1993–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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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?

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

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071002	Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (CCRP) Reagent	Beckman Coulter, Inc.	2007	0
K971283	Synchron Systems Cal 5 Plus	Beckman Instruments, Inc.	1997	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 17, 2003	Not classified	Z-1152-04	Other	The ASO (MPE) assayed in Buffer cannot be programmed or calibrated using Array Calculator 5.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K071002 (Beckman Coulter, Inc., 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GTQ devices

GTQ Antistreptolysin - Titer/Streptolysin O Reagent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GTQ

FDA has decided no GTQ device since 2007.

Median 510(k) review, days · GTQ

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

Recalls per year · GTQ

1in 2008

2007high 1 (2007) · low 0 (2009)2026

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

Adverse event reports per year · GTQ

1in 2025

2007high 1 (2011) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	1	0
2008	—	1	0
2009	—	0	0
2010	—	0	0
2011	—	0	1
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	1
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	1
2025	—	0	1
2026	—	0	—

https://510kreport.com/device/K926236 · printed Nov 6, 2026

Cite this page

510(k) Report. “K926236: Beckman Anti-Streptolysin O Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926236

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026