510(k) Report

510(k) · Cleared

Cleared

Apl Iga Elisa Kit

K021398510(k) TraditionalCleared Aug 27, 2002117-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

Louisville Apl Diagnostics, Inc. · MID System, Test, Anticardiolipin Immunological

Cleared on Aug 27, 2002 after a 117-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Aug 27, 2002
Review
117 days
Class
Class II
Product code
MID
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K021398Source: 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), 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
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What was it cleared against?

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

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 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?

The Antiphospholipid Syndrome is a clinical diagnosis supported by finding a positive antiphospholipid ELISA and/or lupus anticoagulant test. Indications for the test include: patients with unexplained venous thrombosis, particularly if recurrent or at unusual sites as the inferior vena cava or renal veins; unexplained venous thrombosis, particularly if recurrent or at unusual sites as the inferior vena cava or renal veins; unexplained occlusion of the…

Read the full statement (194 words)

The Antiphospholipid Syndrome is a clinical diagnosis supported by finding a positive antiphospholipid ELISA and/or lupus anticoagulant test. Indications for the test include: patients with unexplained venous thrombosis, particularly if recurrent or at unusual sites as the inferior vena cava or renal veins; unexplained venous thrombosis, particularly if recurrent or at unusual sites as the inferior vena cava or renal veins; unexplained occlusion of the arterial circulation resulting in stroke, myocardial infarction, or peripheral gangrene. In patients with unexplained venous thrombosis, other disorder should be excluded, such as protein C, S, or antithrombin I11 deficiency, as well as malignancy or the nephrotic syndrome. The test is also indicated in women with one or more unexplained second or third trimester pregnancy losses or two or more first trimester losses. Finally, patients with unexplained thrombocytopenia as well as other abnormalities said to be associated with the Antiphospholipid Syndrome should be tested.

The APL@IgA ELISA Kit is a semiquantitative enzyme linked immunosorben assay (ELISA) for use as an aid in diagnosing the Antiphospholipid Syndrome (A P S) in patients presenting with thrombosis, pregnancy losses and/or thrombocytopenia. It enables measurement of IgA anticardiolpin antibody levels in human serum.

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

Cite this page

510(k) Report. “K021398: Apl Iga Elisa Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021398

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026