FDA product code · Clinical chemistry

Test, Albumin Cobalt Binding

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

NJVClass II21 CFR 862.1215510(k) required2 decisions since 20030 recalls

2 FDA decisions since 2003. No recall names this code. The most-cited predicate is K023824, named by 1 later device.

The Albumin Cobalt Binding Test is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with other tests such as ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin.

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 NJV 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 · NJV

FDA has decided no NJV device since 2007.

Median 510(k) review, days · NJV

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

Recalls per year · NJV

No recall names NJV since 2007.

Adverse event reports per year · NJV

No MAUDE report names NJV since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in NJV? 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 862.1215.

MMI Immunoassay Method, Troponin Subunit CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes JHX Fluorometric Method, Cpk Or Isoenzymes JHT Chromatographic Separation, Cpk Isoenzymes JHW U.V. Method, Cpk Isoenzymes JHS Differential Rate Kinetic Method, Cpk Or…MYT Biosensor, Immunoassay, Cpk Or Isoenzymes JHY Colorimetric Method, Cpk Or Isoenzymes

Test, Albumin Cobalt Binding

Which predicates do NJV devices cite most?

Which NJV devices have the deepest lineage?

What has FDA decided in NJV lately?

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