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ACCU NEWS Ovulation Test + Pregnancy Test Combo

Model strip · CORETESTS, INC. · DI 00850042559017

LCX — Kit, Test, Pregnancy, Hcg, Over The Counter · Class II · 21 CFR 862.1155

NGE — Test, Luteinizing Hormone (Lh), Over The Counter · Class I · 21 CFR 862.1485

UDILibrary device dossier · generated 2026-09-11 · 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.

11222024-10: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2/device1007
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2024-1002
2025-0702
This device (reports/month)Average device in LCX, NGE (reports/device/month)

Regulatory clearances

  • K150063 SESE 2015-10-02 (k number procode)

Predicate lineage

K150063 — cites (transitively): K043443 (d1) — cited as predicate by K230741

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

Manufacturer compliance record — CORETESTS, INC.

Nothing in the loaded window.