510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053196Substantially Equivalent

Ischemia Albumin Cobalt Binding Test (Acb Test)

Inverness Medical Innovations, Inc., Waltham MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053196 is the FDA 510(k) clearance record for ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST), a class II device, cleared for Inverness Medical Innovations, Inc. on under FDA product code NJV (Test, Albumin Cobalt Binding). FDA's definition for product code NJV reads: "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...". FDA records list 6 510(k) clearances for Inverness Medical Innovations, Inc., from to . As of , FDA records show no recalls naming K053196.

Clearance record

Decision date
Received
(30 days to decision)
Product code
NJV Test, Albumin Cobalt Binding
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Inverness Medical Innovations, Inc. 51 Sawyer Rd., Suite 200, Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NJV

Trailing 12 months

FDA records hold no clearances under product code NJV in the trailing twelve months.

FDA records show no clearances under product code NJV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NJV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260