510(k) · Cleared

Cleared

Sigma Diagnostics Infinity Uric Acid Reagent Kit

K982251510(k) TraditionalCleared Aug 18, 199853-day reviewClass I21 CFR 862.1775

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

Sigma Diagnostics, Inc. · CDO Acid, Uric, Uricase (U.V.)

Cleared on Aug 18, 1998 as substantially equivalent to K971485 (Trace America, Inc., 1997) after a 53-day review. Its family tree reaches back 1 generation to 1997.

Decided: Aug 18, 1998
Review: 53 days
Class: Class I
Product code: CDO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K971485 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK971485 Uric Acid - Incorporating Dynamic Stabilization Technology - (DST)Trace America, Inc. · 1997
This deviceK982251 Sigma Diagnostics Infinity Uric Acid Reagent KitSigma Diagnostics, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971485	Uric Acid - Incorporating Dynamic Stabilization Technology - (DST)	Trace America, Inc.	1997	—
0 (this device)	K982251	Sigma Diagnostics Infinity Uric Acid Reagent Kit	Sigma Diagnostics, Inc.	1998	—

FIG. 1 — Lineage of K982251, 1997–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Planning a device in CDO? 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K971485	Uric Acid - Incorporating Dynamic Stabilization Technology - (DST) Summary page 1 …INITY™ Uric Acid Reagent (Procedure No. 684) is substantially equivalent to, and is the same product as the TRACE Scientific Uric Acid Reagent kit cleared by the FDA as K971485. References — Searcy RL: Diagnostic Biochemistry. McGraw-Hill, New York, NY, 1969 2. Henry RJ, Common C, Winkelman JW (eds),…	Trace America, Inc.	1997	—

Also cleared against K971485: 2 other devices →

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.
2 other devices also cite its predicate K971485.

How does its category compare?

All CDO devices

CDO Acid, Uric, Uricase (U.V.): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CDO

FDA has decided no CDO device since 2007.

Median 510(k) review, days · CDO

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

Recalls per year · CDO

No recall names CDO since 2007.

Adverse event reports per year · CDO

No MAUDE report names CDO since 2007.

View these four charts as a table

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

What is it indicated for?

The Sigma Diagnostics INFINITY ™ Uric Acid Reagent is a device intended to measure

uric acid in serum. Measurements obtained by the device are used in the diagnosis

and treatment of numerous renal and metabolic disorders, including renal failure, gout,

leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving

cytotoxic drugs.

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

https://510kreport.com/device/K982251 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982251: Sigma Diagnostics Infinity Uric Acid Reagent Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982251

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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