510(k) Report

FDA product code · Microbiology

Enzyme Linked Immunoabsorbent Assay, Rubeola Igm

PCLClass I21 CFR 866.3520510(k) exempt1 decision since 20140 recalls

FDA lists PCL as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2014. No recall names this code.

The qualitative detection of measles specific IgM antibodies in serum or plasma.

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, microbiology panel

Twenty years of PCL 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.

FDA decisions per year · PCL

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PCL

Too few PCL 510(k)s in any year since 2007 to give a median.

Recalls per year · PCL

No recall names PCL since 2007.

Adverse event reports per year · PCL

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2025

MAUDE reports naming product code PCL, 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—00
20090—00
20100—00
20110—00
20120—00
20130—00
20141—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — PCL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PCL? 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

Which PCL devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K140455Captia Measles IgmTrinity Biotech USA · 20141generation

What has FDA decided in PCL lately?

  • K140455Captia Measles IgmTrinity Biotech USA · 20142 recalls

The one PCL decision →

Related product codes

Other codes under 21 CFR 866.3520.

GRI Antiserum, Neutralization, RubeolaGRE Antiserum, Fluorescent, RubeolaLJB Enzyme Linked Immunoabsorbent Assay, Rubeola IggGRH Antigen, Ha (Including Ha Control), RubeolaGRF Antiserum, Cf, RubeolaGRG Antiserum, Hai, RubeolaGRJ Antigen, Cf, (Including Cf Control), Rubeola