510(k) · Cleared

Cleared

Theophylline Enzyme Immunoassay

K952596510(k) TraditionalCleared Aug 11, 199566-day reviewClass II21 CFR 862.3880

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

Diagnostic Reagents, Inc. · KLS Enzyme Immunoassay, Theophylline

Cleared on Aug 11, 1995 after a 66-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided: Aug 11, 1995
Review: 66 days
Class: Class II
Product code: KLS
Recalls: None
Predicates: 0

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

This deviceK952596 Theophylline Enzyme ImmunoassayDiagnostic Reagents, Inc. · 1995
Descendant · cites it directly · 0 of its ownK973583 Ace Theophylline Reagent, Theo CalibratorsSchiapparelli Biosystems, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all

K973583Ace Theophylline Reagent, Theo CalibratorsSchiapparelli Biosystems, 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)	K952596	Theophylline Enzyme Immunoassay	Diagnostic Reagents, Inc.	1995	—
+1	K973583	Ace Theophylline Reagent, Theo Calibrators	Schiapparelli Biosystems, Inc.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K952596, 1995–1997Source: 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 lists a 510(k) statement for it but has not posted the file, 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
K973583	Ace Theophylline Reagent, Theo Calibrators	Schiapparelli Biosystems, Inc.	1997	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, K973583 (Schiapparelli Biosystems, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KLS devices

KLS Enzyme Immunoassay, Theophylline: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLS

FDA has decided no KLS device since 2007.

Median 510(k) review, days · KLS

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

Recalls per year · KLS

2in 2013

2007high 2 (2012) · low 0 (2007)2026

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

Adverse event reports per year · KLS

1in 2025

2007high 2 (2009) · low 0 (2008)2025

MAUDE reports naming product code KLS, 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	1
2008	—	0	0
2009	—	0	2
2010	—	0	0
2011	—	0	1
2012	—	2	0
2013	—	2	0
2014	—	0	0
2015	—	0	0
2016	—	0	2
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	1
2026	—	0	—

https://510kreport.com/device/K952596 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952596: Theophylline Enzyme Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952596

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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