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QUANTA Flash® aCL IgM Reagents

Model 701238 · INOVA DIAGNOSTICS, INC. · DI 08426950544210

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

UDILibrary device dossier · generated 2026-09-15 · 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.

01112023-03: 0 reports for this device; peer average 1/device03
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2023-0301
This device (reports/month)Average device in MID (reports/device/month)

Regulatory clearances

  • K092181 SESE 2010-03-11 (k number procode)

Predicate lineage

K092181 — cites (transitively): K022992 (d1) — cited as predicate by K221359, K223093

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

Manufacturer compliance record — INOVA DIAGNOSTICS, INC.

Nothing in the loaded window.