510(k) · Cleared

Cleared

Duet HS-CRP Lit Assay, Catalog Number: 4010, Duet HS-CRP Calibrator Set, Catalog Number: 4511

K050713510(k) TraditionalCleared Jun 6, 200580-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

Good Biotech Corp. · DCN System, Test, C-Reactive Protein

Cleared on Jun 6, 2005 as substantially equivalent to K023828 (Kamiya Biomedical Co., 2003) after an 80-day review. Its family tree reaches back 1 generation to 2003.

Decided: Jun 6, 2005
Review: 80 days
Class: Class II
Product code: DCN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K023828 (2003). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK023828 K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D…Kamiya Biomedical Co. · 2003 · Recalled
This deviceK050713 Duet HS-CRP Lit Assay, Catalog Number: 4010, Duet HS-CRP Calibrator…Good Biotech Corp. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K023828	K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP…	Kamiya Biomedical Co.	2003	1
0 (this device)	K050713	Duet HS-CRP Lit Assay, Catalog Number: 4010, Duet HS-CRP Calibrator Set…	Good Biotech Corp.	2005	—

FIG. 1 — Lineage of K050713, 2003–2005Source: 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 DCN? 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 DCN device

#1 K232624 CardioPhase® hsCRPscore 6.7 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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
*	K023828	K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP… Summary page 1 …Calibrator (21CFR 862.1150) Predicate Device Trade name, K-ASSAY CRP (3) K-ASSAY Multi-Calibrator D 510O(k) number K023828 Description Duet hs-CRP LIT kit is the ready-to-use reagent suitable for quantif…	Kamiya Biomedical Co.	2003	1

Also cleared against K023828: 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 a recall.
2 other devices also cite its predicate K023828.

How does its category compare?

All DCN devices

DCN System, Test, C-Reactive Protein: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DCN

2in 2023

2007high 3 (2009) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DCN

234in 2018

2007high 234 (2018) · low 111 (2009)2026

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

Recalls per year · DCN

1in 2020

2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · DCN

7in 2025

2007high 8 (2019) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	2	—	1	0
2009	3	111	0	0
2010	1	—	0	2
2011	0	—	0	5
2012	1	—	0	2
2013	0	—	0	0
2014	0	—	0	2
2015	0	—	0	2
2016	0	—	0	1
2017	1	—	0	0
2018	3	234	0	2
2019	0	—	1	8
2020	1	—	1	0
2021	0	—	0	1
2022	0	—	0	1
2023	2	—	0	3
2024	0	—	0	5
2025	0	—	0	7
2026	0	—	1	—

What is it indicated for?

Good Biotech Corp. Duet hs-CRP LIT Assay is intended to be used as a high sensitive assay for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry (LIT). Highly sensitive measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

Good Biotech Corp. Duet hs-CRP Calibrator Set is intended to be used with Duet hs-CRP LIT Assay for the quantitative determination of C-reactive protein in serum samples.

For In Vitro Diagnostic Use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050713 · printed Nov 5, 2026

Cite this page

510(k) Report. “K050713: Duet HS-CRP Lit Assay, Catalog Number: 4010, Duet HS-CRP Calibrator Set, Catalog Number: 4511.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050713

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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