DeviceClearance

Product code NJV— Clinical Chemistry

ALBUMIN COBALT BINDING TEST (ACB TEST)

Classification name
Test, Albumin Cobalt Binding
Device class
Class 2
Regulation
21 CFR 862.1215
Advisory panel
Clinical Chemistry
Total cleared
2
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code NJV under 21 CFR 862.1215, via openFDA

Market context for product code NJV

FDA has cleared 2 devices under product code NJV between 2003 and 2005, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NJV

Recent clearances under product code NJV

Data sourced from openFDA. This site is unofficial and independent of the FDA.