510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Olympus Uric Acid Reagent, Model OSR6X98

K062862510(k) TraditionalCleared Apr 6, 2007193-day reviewClass I21 CFR 862.1775Recalls 3

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

Olympus America, Inc. · KNK Acid, Uric, Uricase (Colorimetric)

Cleared on Apr 6, 2007 after a 193-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 3 times.

Decided
Apr 6, 2007
Review
193 days
Class
Class I
Product code
KNK
Recalls
3
Predicates
0

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

FIG. 1 — Lineage of K062862Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 24, 2018Class IIZ-0211-2020Nonconforming Material/ComponentNAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
Apr 13, 2016Class IIZ-1932-2016Device DesignBeckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.
Dec 15, 2014Class IIZ-1024-2015Under Investigation by firmN-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase…

No ancestor or descendant has a Class I recall.

How does its category compare?

All KNK devices

KNK Acid, Uric, Uricase (Colorimetric): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · KNK

1in 2011

2007: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNK

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

Recalls per year · KNK

1in 2018

2009: 22013: 12014: 12016: 22018: 12026 (partial year): 1
2007high 2 (2009) · low 0 (2007)2026

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

Adverse event reports per year · KNK

2in 2025

2007: 12011: 72019: 12020: 22023: 42024: 22025: 2
2007high 7 (2011) · low 0 (2008)2025

MAUDE reports naming product code KNK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
20080—00
20090—20
20100—00
20111—07
20120—00
20130—10
20140—10
20150—00
20160—20
20170—00
20180—10
20190—01
20200—02
20210—00
20220—00
20230—04
20240—02
20250—02
20260—1—

What is it indicated for?

System reagent for the quantitative determination of Uric Acid in human serum,

heparinized plasma and urine on OLYMPUS analyzers

Measurements of Uric Acid 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 as stated in the FDA 510(k) statement.

More from Olympus America, Inc.

149 FDA decisions under this applicant name. See the company

  • K111788Endoeye HD IIOlympus America, Inc. · 20122 recalls
  • K081615Olympus Cea - Carcinoembryonic AntigenOlympus America, Inc. · 2009
  • K073489Olympus Iga ReagentOlympus America, Inc. · 20081 recall
  • K073490Olympus Igg ReagentOlympus America, Inc. · 2008
  • K073487Olympus Igm ReagentOlympus America, Inc. · 20081 recall

Recent decisions in KNK

The KNK category page

  • K102568Uric Acid Model 3P39Abbott Laboratories · 2011
  • K040467Vitalab Uric Acid ReagentClinical Data, Inc. · 2004
  • K031044Atac Pak Uric Acid Reagent and Atac CalibratorClinical Data, Inc. · 2003
  • K022096Uric Acid Assay for the Advia Integrated Modular SystemBayer Diagnostics Corp. · 2003
  • K023550Wiener Lab Uricostat Enzimatico AA LiquidaWiener Laboratories Saic · 2002

https://510kreport.com/device/K062862 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062862: Olympus Uric Acid Reagent, Model OSR6X98.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062862

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026