510(k) Report

510(k) · Cleared

Cleared

Olympus CRP Latex Reagent, OSR6199; Olympus CRP Latex Calibrator Normal Set, ODC0026; Olympus CRP Latex Calibrator High

K051564510(k) TraditionalCleared Aug 22, 200569-day reviewClass II21 CFR 866.5270

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

Olympus America, Inc. · NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

Cleared on Aug 22, 2005 after a 69-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.

Decided
Aug 22, 2005
Review
69 days
Class
Class II
Product code
NQD
Recalls
None
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2016: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared20052010201520202025
  1. This deviceK051564 Olympus CRP Latex Reagent, OSR6199; Olympus CRP Latex Calibrator…Olympus America, Inc. · 2005
  2. Descendant · cites it directly · 2 of its ownK161837 ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry…Beckman Coulter, Inc. · 2016
  3. Descendant · 2 generations on · 0 of its ownK220977 ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry…Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK183375 Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium…Horiba, Ltd. · 2019
  5. Descendant · cites it directly · 0 of its ownK141689 FastPack High Sensitivity C-Reactive Protein Immunoassay, High…Qualigen, Inc. · 2015

Most influential descendants

Showing 4 of 4 · See all
  • K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry AnalyzerBeckman Coulter, Inc. · 2016 · cites it directly2descendants
  • K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023 · 2 generations on0descendants
  • K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride…Horiba, Ltd. · 2019 · 2 generations on0descendants
  • K141689FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…Qualigen, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K051564Olympus CRP Latex Reagent, OSR6199; Olympus CRP Latex Calibrator Normal Set…Olympus America, Inc.2005—
+1K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry AnalyzerBeckman Coulter, Inc.2016—
+2K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.20237
+2K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium…Horiba, Ltd.2019—
+1K141689FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity…Qualigen, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201910
202310
FIG. 1 — Lineage of K051564, 2005–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

Planning a device in NQD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NQD device

  1. #1 K260026 Tina-quant Cardiac high sensitivity CRP IIIscore 12.3 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

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

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry AnalyzerBeckman Coulter, Inc.20162
K141689FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…Qualigen, Inc.20150

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, K161837 (Beckman Coulter, Inc., 2016) has gone furthest, with 2 descendants of its own.

How does its category compare?

All NQD devices

NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NQD

1in 2024

2007: 32008: 12018: 12022: 12024: 12026 (partial year): 1
2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NQD

59in 2007

2007: 59 days median
2007high 59 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NQD

2in 2015

2015: 2
2007high 2 (2015) · low 0 (2007)2026

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

Adverse event reports per year · NQD

2in 2025

2007: 12010: 12011: 52012: 22016: 12017: 12021: 22023: 22024: 12025: 2
2007high 5 (2011) · low 0 (2008)2025

MAUDE reports naming product code NQD, 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
200735901
20081—00
20090—00
20100—01
20110—05
20120—02
20130—00
20140—00
20150—20
20160—01
20170—01
20181—00
20190—00
20200—00
20210—02
20221—00
20230—02
20241—01
20250—02
20261—0—

What is it indicated for?

Olympus System Reagent and calibrators for the quantitative determination of C-Reactive Protein in human serum and plasma on OLYMPUS Analyzers. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk of future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, maybe useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

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 NQD

The NQD category page

  • K260026Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics · 2026
  • K233242Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics, Inc. · 2024
  • K212559CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbH · 2022
  • K173833CRP VarioSENTINEL CH. SpA · 2018
  • K081294Advia Chemistry Cardiophase High Sensitivity C-Reactive Protein (Hscrp), CalibratorsSiemens Healthcare Diagnostics, Inc. · 20082 recalls

https://510kreport.com/device/K051564 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051564: Olympus CRP Latex Reagent, OSR6199; Olympus CRP Latex Calibrator Normal Set, ODC0026; Olympus CRP Latex Calibrator High.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051564

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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