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Aptiva® APS IgM Reagent

Model 725140 · INOVA DIAGNOSTICS, INC. · DI 08430793040853

MID — System, Test, Anticardiolipin Immunological · Class II · 21 CFR 866.5660

MSV — System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) · Class II · 21 CFR 866.5660

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2023-03	0	1

This device (reports/month)Average device in MID, MSV (reports/device/month)

Regulatory clearances

K223093 SESE 2024-12-17 (k number procode)

Predicate lineage

K223093 — cites (transitively): K091556 (d1), K092181 (d1), K970551 (d1), K022992 (d2)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — INOVA DIAGNOSTICS, INC.

Nothing in the loaded window.