510(k) · Cleared

Cleared

Quickvue in-Line One Step Strep a Test (Modification)

K954257510(k) TraditionalCleared Oct 20, 199585-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

Quidel Corp. · GTZ Antisera, All Groups, Streptococcus Spp.

Cleared on Oct 20, 1995 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Oct 20, 1995
Review: 85 days
Class: Class I
Product code: GTZ
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK954257 Quickvue in-Line One Step Strep a Test (Modification)Quidel Corp. · 1995
Descendant · cites it directly · 0 of its ownK023766 Acon Strep a Twist Test DeviceAcon Laboratories Co. · 2003 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K023766Acon Strep a Twist Test DeviceAcon Laboratories Co. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K954257	Quickvue in-Line One Step Strep a Test (Modification)	Quidel Corp.	1995	—
+1	K023766	Acon Strep a Twist Test Device	Acon Laboratories Co.	2003	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K954257, 1995–2003Source: 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.

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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023766	Acon Strep a Twist Test Device	Acon Laboratories Co.	2003	0

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?

Of its descendants, K023766 (Acon Laboratories Co., 2003) has gone furthest, with 0 descendants of its own.

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

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

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

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	1	0
2010	—	0	0
2011	—	0	2
2012	—	0	0
2013	—	0	1
2014	—	0	0
2015	—	0	0
2016	—	0	1
2017	—	0	2
2018	—	0	8
2019	—	0	1
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	4
2025	—	0	10
2026	—	0	—

https://510kreport.com/device/K954257 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954257: Quickvue in-Line One Step Strep a Test (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954257

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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