510(k) · Cleared

Cleared

Uric Acid - Incorporating Dynamic Stabilization Technology - (DST)

K971485510(k) TraditionalCleared May 27, 199734-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

Trace America, Inc. · CDO Acid, Uric, Uricase (U.V.)

Cleared on May 27, 1997 after a 34-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.

Decided: May 27, 1997
Review: 34 days
Class: Class I
Product code: CDO
Recalls: None
Predicates: 0

5 later devices descend from it, 3 citing it directly.

This deviceK971485 Uric Acid - Incorporating Dynamic Stabilization Technology - (DST)Trace America, Inc. · 1997
Descendant · cites it directly · 2 of its ownK081276 Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine…Horiba Abx · 2008 · Recalled
Descendant · 2 generations on · 0 of its ownK183375 Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium…Horiba, Ltd. · 2019
Descendant · 2 generations on · 0 of its ownK100263 Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV…Seppim S.A.S. · 2011
Descendant · cites it directly · 0 of its ownK992798 Sigma Diagnostics Infinity Uric Acid Reagent, Models 684-25…Sigma Diagnostics, Inc. · 1999
Descendant · cites it directly · 0 of its ownK982251 Sigma Diagnostics Infinity Uric Acid Reagent KitSigma Diagnostics, Inc. · 1998

Most influential descendants

Showing 5 of 5 · See all

K081276Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HHoriba Abx · 2008 · cites it directly2descendants
K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride…Horiba, Ltd. · 2019 · 2 generations on0descendants
K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S. · 2011 · 2 generations on0descendants
K992798Sigma Diagnostics Infinity Uric Acid Reagent, Models 684-25, 684-100P, 684-500P…Sigma Diagnostics, Inc. · 1999 · cites it directly0descendants
K982251Sigma Diagnostics Infinity Uric Acid Reagent KitSigma Diagnostics, Inc. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K971485	Uric Acid - Incorporating Dynamic Stabilization Technology - (DST)	Trace America, Inc.	1997	—
+1	K081276	Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/H	Horiba Abx	2008	1
+2	K183375	Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium…	Horiba, Ltd.	2019	—
+2	K100263	Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL Reagents	Seppim S.A.S.	2011	—
+1	K992798	Sigma Diagnostics Infinity Uric Acid Reagent, Models 684-25, 684-100P…	Sigma Diagnostics, Inc.	1999	—
+1	K982251	Sigma Diagnostics Infinity Uric Acid Reagent Kit	Sigma Diagnostics, Inc.	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2008	1	0
2011	1	0
2019	1	0

FIG. 1 — Lineage of K971485, 1997–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K081276	Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/H	Horiba Abx	2008	2
K992798	Sigma Diagnostics Infinity Uric Acid Reagent, Models 684-25, 684-100P, 684-500P…	Sigma Diagnostics, Inc.	1999	0
K982251	Sigma Diagnostics Infinity Uric Acid Reagent Kit	Sigma Diagnostics, Inc.	1998	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, K081276 (Horiba Abx, 2008) has gone furthest, with 2 descendants of its own.

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?

intended for the In Vitro, quantitative determination of Uric Acid in human serum and urine for clinical diagnosis.

This Uric Acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this 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, CFR 862.1775

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K971485 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971485: Uric Acid - Incorporating Dynamic Stabilization Technology - (DST).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971485

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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