510(k) Report

FDA applicant

Qualigen, Inc.

Carlsbad, CA15 decisions2000–20197 recalls

FDA records 15 decisions for Qualigen, Inc. (Carlsbad, CA) from 2000 to 2019: 15 510(k) clearances. Most are in product codes CDZ (Radioimmunoassay, Testosterones And…) and JIT (Calibrator, Secondary). Its devices cite 13 predicates, 3 of them its own earlier devices. 7 recalls are linked to its devices.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Qualigen, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007: 22010: 12011: 12013: 22015: 12019: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2024

2013: 32017: 12019: 12024: 2
2007high 3 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Qualigen, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Qualigen, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CDZRadioimmunoassay, Testosterones And Dihydrotestosterone3decisions
  • JITCalibrator, Secondary2decisions
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)2decisions
  • JLWRadioimmunoassay, Thyroid-Stimulating Hormone2decisions
  • DCKC-Reactive Protein, Antigen, Antiserum, And Control1decision
  • LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers1decision

Also: CEC (1), JJY (1), MRG (1), JHI (1).

Whose devices does it build on?

Its devices cite 13 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K052301Fastpack TSH ImmunoassayQualigen, Inc. · 20062cite it
  • K003095Fastpack ControlQualigen, Inc. · 20001cites it
  • K021972Fastpack Total Testosterone ImmunoassayQualigen, Inc. · 20021cites it

What has FDA decided for it lately?

  • K182521FastPack IP Sex Hormone Binding Globulin ImmunoassayQualigen, Inc. · 20192 recalls
  • K141689FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator…Qualigen, Inc. · 2015
  • 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
  • K072264Fastpack HCG ImmunoassayQualigen, Inc. · 2007
  • K062957Fastpack Total Psa Method Verification KitQualigen, Inc. · 2007

All 15 as Qualigen, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K182521The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the…Dec 3, 2024Class III
  • K052301FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP…Aug 26, 2024Class II
  • K182521The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement…Nov 6, 2019Class II
  • K123983Qualigen (R) The FastPack (R) IP Vitamin D Complete Immunoassay Kit, catalog number…Jul 7, 2017Class II
  • K021972FastPack Testosterone Immunoassay Chemilunescence assay for the determination of…Nov 8, 2013Class II
  • K123983FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for…Nov 8, 2013Class II