510(k) Report

FDA product code · Clinical chemistry

Biosensor, Immunoassay, Cpk Or Isoenzymes

MYTClass II21 CFR 862.1215510(k) required3 decisions since 19990 recalls

3 FDA decisions since 1999. No recall names this code.

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 MYT 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 · MYT

FDA has decided no MYT device since 2007.

Median 510(k) review, days · MYT

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

Recalls per year · MYT

No recall names MYT since 2007.

Adverse event reports per year · MYT

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code MYT, 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
20140—00
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — MYT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MYT? 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 MYT devices have the deepest lineage?

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

  • K033155Biocentrex Cardiac PanelBiocentrex · 20042generations

What has FDA decided in MYT lately?

  • K051433I-Stat Creatine Kinase MB (CK-MB)I-Stat Corporation · 20054 recalls
  • K033155Biocentrex Cardiac PanelBiocentrex · 2004
  • K984433Quantech CK-MB AssayQuantech, Ltd. · 1999

All 3 MYT decisions →

Related product codes

Other codes under 21 CFR 862.1215.

MMI Immunoassay Method, Troponin SubunitCGS Nad Reduction/Nadh Oxidation, Cpk Or IsoenzymesJHX Fluorometric Method, Cpk Or IsoenzymesJHT Chromatographic Separation, Cpk IsoenzymesJHW U.V. Method, Cpk IsoenzymesNJV Test, Albumin Cobalt BindingJHS Differential Rate Kinetic Method, Cpk Or…JHY Colorimetric Method, Cpk Or Isoenzymes