510(k) Report

510(k) · Cleared

Cleared

Reaads Igg Anti-Prothrombin Semi-Quantitative Test Kit

K001352510(k) TraditionalCleared Apr 9, 2001346-day reviewClass II21 CFR 866.5820

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

Corgenix, Inc. · DHC System, Test, Systemic Lupus Erythematosus

Cleared on Apr 9, 2001 after a 346-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 9, 2001
Review
346 days
Class
Class II
Product code
DHC
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K001352Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All DHC devices

DHC System, Test, Systemic Lupus Erythematosus: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DHC

FDA has decided no DHC device since 2007.

Median 510(k) review, days · DHC

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

Recalls per year · DHC

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DHC

No MAUDE report names DHC since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—10
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Corgenix, Inc.

23 FDA decisions under this applicant name. See the company

  • K072032Igg Anti-Atherox Test KitCorgenix, Inc. · 2008
  • K062025Aspirinworks Test Kit (11-Dehydro Thromboxane B2), Model 12136Corgenix, Inc. · 2007
  • K042680Rhigene Hep-Ana Test SystemCorgenix, Inc. · 2004
  • K032139Reaads Von Willebrand Factor Activity Test Kit, Model 10826Corgenix, Inc. · 2004
  • K034013Reaads Dsdna Quantitative Test Kit, Model 022-001Corgenix, Inc. · 2004

Recent decisions in DHC

The DHC category page

  • K001398Reaads Igm Anti-Prothrombin Semi-Quantitative Test KitCorgenix, Inc. · 2001
  • K930247Human a-DS Dna Eia Kit for Diagnostic UseThe Binding Site, Ltd. · 1993
  • K930421Elias Dsdna AbsElias U.S.A., Inc. · 1993
  • K914801Immunowell Dsdna Antibody TestGeneral Biometrics, Inc. · 1991
  • K885048Access R-Clone Ana Profile AssayLipogen, Inc. · 1989

https://510kreport.com/device/K001352 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001352: Reaads Igg Anti-Prothrombin Semi-Quantitative Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001352

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026