FDA product code · Clinical chemistry

Amniotic Fluid Protein Immunoassay

Name: FDA decisions, review times, recalls and adverse event reports for product code PDS
Creator: 510(k) Report

PDSClass I21 CFR 862.1550510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

To detect specified amniotic fluid proteins in cervicovaginal samples

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

FIG. A — Illustration, clinical chemistry panel

Twenty years of PDS at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — PDS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PDS? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 862.1550.

OAM Immunoassay, Insulin-Like Growth Factor…LNW Paper, Obstetric Ph NQM Immunoassay For Detection Of Amniotic Fluid…CEN Dye-Indicator, Ph (Urinary, Non-Quantitative)