510(k) · Cleared
ClearedSigma Diagnostics Infinity Uric Acid Reagent, Models 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Diagnostics, Inc. · CDO Acid, Uric, Uricase (U.V.)
Cleared on Sep 28, 1999 as substantially equivalent to K971485 (Trace America, Inc., 1997) after a 40-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Sep 28, 1999
- Review
- 40 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.
- Root · 1 generation backK971485 Uric Acid - Incorporating Dynamic Stabilization Technology - (DST)Trace America, Inc. · 1997
- This deviceK992798 Sigma Diagnostics Infinity Uric Acid Reagent, Models 684-25…Sigma Diagnostics, Inc. · 1999
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) | K992798 | Sigma Diagnostics Infinity Uric Acid Reagent, Models 684-25, 684-100P… | Sigma Diagnostics, Inc. | 1999 | — |
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
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 | Decided |
|---|---|---|---|
| * | K971485 | Uric Acid - Incorporating Dynamic Stabilization Technology - (DST)Summary page 1…FINITY™ 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. Correlation studies to Sigma Diagnostics Uric Acid Reagent, Procedure No. 685 (K853357) using plasma samples yielded a regress… | 1997 |
| † | K853357 | Uric Acid Reagent | 1985 |
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 devicesCDO 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 | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sigma Diagnostics INFINITY™ Uric Acid Reagent is a device intended to measure uric acid in serum, plasma or urine. 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/K992798 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992798: Sigma Diagnostics Infinity Uric Acid Reagent, Models 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992798
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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