510(k) Report

510(k) · Cleared

Cleared

Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001

K022992510(k) SpecialCleared Sep 25, 200216-day reviewClass II21 CFR 866.5660

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

Corgenix, Inc. · MID System, Test, Anticardiolipin Immunological

Cleared on Sep 25, 2002 after a 16-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.

Decided
Sep 25, 2002
Review
16 days
Class
Class II
Product code
MID
Recalls
None
Predicates
0

6 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2012: 1 descendant cleared2010: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant cleared2013: 1 descendant cleared200020052010201520202025
  1. This deviceK022992 Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model…Corgenix, Inc. · 2002
  2. Descendant · cites it directly · 3 of its ownK092181 Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm ControlsInstrumentation Laboratory CO · 2010
  3. Descendant · 2 generations on · 0 of its ownK223093 Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc. · 2024
  4. Descendant · 2 generations on · 0 of its ownK221359 ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2…Instrumentation Laboratory CO · 2023
  5. Descendant · 2 generations on · 0 of its ownK130528 Bioplex 2200 Apls IgmBio-Rad Laboratories · 2013 · Recalled
  6. Descendant · cites it directly · 0 of its ownK103834 Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control SetsBio-Rad Laboratories · 2012

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12012: 12013: 12023: 12024: 1
2008high 1 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all
  • K092181Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm ControlsInstrumentation Laboratory CO · 2010 · cites it directly3descendants
  • K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc. · 2024 · 2 generations on0descendants
  • K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO · 2023 · 2 generations on0descendants
  • K130528Bioplex 2200 Apls IgmBio-Rad Laboratories · 2013 · 2 generations on0descendants
  • K103834Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control SetsBio-Rad Laboratories · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022992Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001Corgenix, Inc.2002—
+1K092181Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm ControlsInstrumentation Laboratory CO2010—
+2K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc.2024—
+2K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2…Instrumentation Laboratory CO2023—
+2K130528Bioplex 2200 Apls IgmBio-Rad Laboratories20131
+1K103834Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control SetsBio-Rad Laboratories2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201210
201310
202310
202410
FIG. 1 — Lineage of K022992, 2002–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MID? 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 MID device

  1. #1 K223093 Aptiva APS IgG Reagent; Aptiva APS IgM Reagentscore 8.8 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092181Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm ControlsInstrumentation Laboratory CO20103
K103834Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control SetsBio-Rad Laboratories20120
K072032Igg Anti-Atherox Test KitCorgenix, Inc.20080

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?

  • Of its descendants, K092181 (Instrumentation Laboratory CO, 2010) has gone furthest, with 3 descendants of its own.

How does its category compare?

All MID devices

MID System, Test, Anticardiolipin Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MID

1in 2024

2010: 22011: 12012: 22013: 32024: 1
2007high 3 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MID

234in 2013

2013: 234 days median
2007high 234 (2013)2026

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

Recalls per year · MID

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · MID

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code MID, 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—10
20090—00
20102—00
20111—00
20122—00
2013323400
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—01
20241—00
20250—00
20260—0—

What is it indicated for?

An enzyme-linked immunosorbent assay (ELISA) for the determination of IgG and IgM anti-cardiolipin antibodies in human serum or plasma.

For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).

Indications for use as stated in the FDA 510(k) statement.

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 MID

The MID category page

  • K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc. · 2024
  • K131821Elia (TM) Cardiolipin Iga ImmunoassayPhadia US, Inc. · 2013
  • K130528Bioplex 2200 Apls IgmBio-Rad Laboratories · 20131 recall
  • K120817Quanta Flash Acl Lga, Quanta Flash B2GP1 IgaInova Diagnostics, Inc. · 2013
  • K113020Immulisa Enhanced (TM) Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (Aca) ElisasImmco Diagnostics, Inc. · 2012

https://510kreport.com/device/K022992 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022992: Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022992

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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