510(k) Report

510(k) · Cleared

Cleared

FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit

K141689510(k) TraditionalCleared Jan 7, 2015198-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

Qualigen, Inc. · DCK C-Reactive Protein, Antigen, Antiserum, And Control

Cleared on Jan 7, 2015 as substantially equivalent to K051564 (Olympus America, Inc., 2005) and 2 other predicates after a 198-day review. Its family tree reaches back 6 generations to 1996.

Decided
Jan 7, 2015
Review
198 days
Class
Class II
Product code
DCK
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K961828 (1996). 11 ancestors in all, the oldest K953197 (1995). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2004: 2 other ancestors1995: 1 other ancestor1999: 1 other ancestorK961828 · Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688) · Bio-Rad · 1996K980556 · Liquichek Cardiac Markers Control LT · Bio-Rad · 1998K012656 · Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648 · Bio-Rad · 2001K021498 · Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel · Bio-Rad · 2002K040277 · Liquichek Cardiac Marker Control LT · Bio-Rad Laboratories, Inc. · 2004K050537 · Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT, Liquichek Cardiac Markers Plus · Bio-Rad · 200519952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor K050537 · Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT, Liquichek Cardiac Markers Plus · Bio-Rad · 2005K040277 · Liquichek Cardiac Marker Control LT · Bio-Rad Laboratories, Inc. · 2004K021498 · Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel · Bio-Rad · 2002K012656 · Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648 · Bio-Rad · 2001K980556 · Liquichek Cardiac Markers Control LT · Bio-Rad · 1998K961828 · Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688) · Bio-Rad · 1996−50
  1. Root · 6 generations backK961828 Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad · 1996
  2. 5 generations backK980556 Liquichek Cardiac Markers Control LTBio-Rad · 1998
  3. 4 generations backK012656 Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad · 2001
  4. 3 generations backK021498 Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad · 2002
  5. 2 generations backK040277 Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc. · 2004
  6. 1 generation backK050537 Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers…Bio-Rad · 2005
  7. This deviceK141689 FastPack High Sensitivity C-Reactive Protein Immunoassay, High…Qualigen, Inc. · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K961828Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad1996—
−5K980556Liquichek Cardiac Markers Control LTBio-Rad1998—
−4K012656Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad2001—
−3K021498Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad2002—
−2K040277Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc.2004—
−1K050537Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control…Bio-Rad2005—
0 (this device)K141689FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity…Qualigen, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199910
200420
200510
FIG. 1 — Lineage of K141689, 1996–2015Source: 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 DCK? 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 DCK device

  1. #1 K242170 K-ASSAY CRP (Ver.2)score 9.2 · 1 generation · 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? (3)

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
*K051564Olympus CRP Latex Reagent, OSR6199; Olympus CRP Latex Calibrator Normal Set, ODC0026…
Summary page 6
…Unassayed) Devices to Which Substantial Equivalence is Claimed Olympus CRP Latex reagent Olympus America, Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA K051564 Liquichek™ Cardiac Markers Plus Control Bio-Rad Laboratories 4000 Alfred Nobel Drive Hercules, CA 94547 K050537 VITROS Chemistr…
Olympus America, Inc.2005—
*K050537Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT…
Summary page 6
…Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA K051564 Liquichek™ Cardiac Markers Plus Control Bio-Rad Laboratories 4000 Alfred Nobel Drive Hercules, CA 94547 K050537 VITROS Chemistry Products hsCRP Performance Verifier I, II, and III Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Roch…
Bio-Rad2005—
*K041799Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17…
Summary page 6
…s, CA 94547 K050537 VITROS Chemistry Products hsCRP Performance Verifier I, II, and III Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101 K041799 Device Description The FastPack® High Sensitivity C-Reactive Protein Immunoassay employs a Sandwich immunoassay principle.…
Ortho-Clinical Diagnostics, Inc.20043

Also cleared against K051564: 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?

  • The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
  • 2 of the 11 ancestors have a recall of any class.
  • 1 other device also cites its predicate K051564.

How does its category compare?

All DCK devices

DCK C-Reactive Protein, Antigen, Antiserum, And Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · DCK

1in 2025

2011: 12012: 12015: 22016: 12017: 12019: 22020: 12022: 12025: 1
2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DCK

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

Recalls per year · DCK

1in 2024

2008: 12009: 12013: 12016: 12024: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · DCK

1in 2021

2008: 12011: 12012: 12014: 12021: 1
2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code DCK, 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
20070—00
20080—11
20090—10
20100—00
20111—01
20121—01
20130—10
20140—01
20152—00
20161—10
20171—00
20180—00
20192—00
20201—00
20210—01
20221—00
20230—00
20240—10
20251—00
20260—0—

What is it indicated for?

FastPack® High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack® High Sensitivity C-Reactive Protein Immunoassay is intended for use with the FastPack® Analyzer. Not intended for Point-of-Care use. FastPack® High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack® High Sensitivity…

Read the full statement (119 words)

FastPack® High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack® High Sensitivity C-Reactive Protein Immunoassay is intended for use with the FastPack® Analyzer. Not intended for Point-of-Care use.

FastPack® High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.

FastPack® High Sensitivity C-Reactive Protein Controls are used for quality control of the FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.

FastPack® High Sensitivity C-Reactive Protein Verifiers are used in the quantitative verification of calibration and assay range of the quantitative FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K051564

1 other device cites the same predicate.

  • K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry AnalyzerBeckman Coulter, Inc. · 2016

More from Qualigen, Inc.

15 FDA decisions under this applicant name. See the company

  • K182521FastPack IP Sex Hormone Binding Globulin ImmunoassayQualigen, Inc. · 20192 recalls
  • K123983Fastpack Vitamin D; Immunoassay, Calibrators, Controls, VerifiersQualigen, Inc. · 20132 recalls
  • K123725Fastpack Control KitQualigen, Inc. · 2013
  • K101388Fastpack Testo ImmunoassayQualigen, Inc. · 2011
  • K101390Fastpack TSH ImmunoassayQualigen, Inc. · 2010

Recent decisions in DCK

The DCK category page

  • K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLC · 2025
  • K201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise Diagnostics · 2022
  • K192028Yumizen C1200 CRPHoriba Abx Sas · 2020
  • K192118CRP VarioSENTINEL CH. SpA · 2019
  • K191993Yumizen C1200 CRPHoriba Abx Sas · 2019

https://510kreport.com/device/K141689 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141689: FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141689

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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