510(k) Report

510(k) · Cleared

Cleared

Crpex-HS C-Reactive Protein Lit Assay, Catalog NO. 1010

K020603510(k) TraditionalCleared Jun 13, 2002108-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 13, 2002 as substantially equivalent to K003342 (Wako Chemicals USA, Inc., 2001) after a 108-day review. Its family tree reaches back 1 generation to 2001.

Decided
Jun 13, 2002
Review
108 days
Class
Class II
Product code
DCN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003342 (2001). No later device cites it as a predicate yet.

K003342 · Wako CRP-UL, CRP-UL Calibrator Set · Wako Chemicals USA, Inc. · 2001200020022004
K003342 · Wako CRP-UL, CRP-UL Calibrator Set · Wako Chemicals USA, Inc. · 20010
  1. Root · 1 generation backK003342 Wako CRP-UL, CRP-UL Calibrator SetWako Chemicals USA, Inc. · 2001
  2. This deviceK020603 Crpex-HS C-Reactive Protein Lit Assay, Catalog NO. 1010Good Biotech Corp. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003342Wako CRP-UL, CRP-UL Calibrator SetWako Chemicals USA, Inc.2001—
0 (this device)K020603Crpex-HS C-Reactive Protein Lit Assay, Catalog NO. 1010Good Biotech Corp.2002—
FIG. 1 — Lineage of K020603, 2001–2002Source: FDA 510(k) summaries, read by 510(k) Report · 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 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. #1 K232624 CardioPhase® hsCRPscore 6.7 · 2 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K003342Wako CRP-UL, CRP-UL Calibrator SetWako Chemicals USA, Inc.2001—

Also cleared against K003342: 1 other device →

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.
  • 1 other device also cites its predicate K003342.

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

2007: 12008: 22009: 32010: 12012: 12017: 12018: 32020: 12023: 2
2007high 3 (2009) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DCN

234in 2018

2009: 111 days median2018: 234 days median
2007high 234 (2018) · low 111 (2009)2026

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

Recalls per year · DCN

1in 2020

2008: 12019: 12020: 12026 (partial year): 1
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

2010: 22011: 52012: 22014: 22015: 22016: 12018: 22019: 82021: 12022: 12023: 32024: 52025: 7
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20082—10
2009311100
20101—02
20110—05
20121—02
20130—00
20140—02
20150—02
20160—01
20171—00
2018323402
20190—18
20201—10
20210—01
20220—01
20232—03
20240—05
20250—07
20260—1—

What is it indicated for?

Good Biotech Corp. CRPex-HS C-reactive protein LIT assay is intended to be used for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry (LIT). Measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. For In Vitro Diagnostic Use.

Indications for use as stated in the FDA summary.

Also cleared against K003342

1 other device cites the same predicate.

  • K021882Crpex-HS CRP Calibrator Set, Catalog NO: 1510Good Biotech Corp. · 2002

More from Good Biotech Corp.

8 FDA decisions under this applicant name. See the company

  • K063766Transferrin Tia , Calibrator Set, Control-L,Control-M,Control-H, Model# KT-0105-a,CA-0105-a,B,CGood Biotech Corp. · 2007
  • K052617Ferritin Lit Assay, Catalog NO. 7010; Ferritin Calibrator Set, Catalog NO. 7510; Ferritin Controls, Level-L…Good Biotech Corp. · 2006
  • K050713Duet HS-CRP Lit Assay, Catalog Number: 4010, Duet HS-CRP Calibrator Set, Catalog Number: 4511Good Biotech Corp. · 2005
  • K050576Microalbumin Tia Reagent; Malb Calibrator Set 200; Malb Control-L, Control-HGood Biotech Corp. · 2005
  • K022725Crpex CRP Controls Level L, M, H; Cat. NO.: 3011, 3012, 3013Good Biotech Corp. · 2002

Recent decisions in DCN

The DCN category page

  • K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH · 2023
  • K221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc. · 20232 recalls
  • K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo) · 2020
  • K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group, Ltd. · 2018
  • K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein…The Binding Site Group, Ltd. · 20181 recall

https://510kreport.com/device/K020603 · printed Nov 4, 2026

Cite this page

510(k) Report. “K020603: Crpex-HS C-Reactive Protein Lit Assay, Catalog NO. 1010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020603

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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