510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050029Substantially Equivalent

Cardiompo Test

Prognostix, Inc., Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050029 is the FDA 510(k) clearance record for CARDIOMPO TEST, a class II device, cleared for Prognostix, Inc. on under FDA product code NTV (Myeloperoxidase, Immunoassay, System, Test). FDA's definition for product code NTV reads: "MYELOPEROXIDASE, IMMUNOASSAY, SYSTEM, TEST IS INTENDED TO MEASURE MYELOPEROXIDASE IN HUMAN PLASMA, TO BE USED IN CONJUNCTION WITH CLINICAL HISTORY, ECG AND CARDIAC BIOMARKERS TO EVALUATE PATIENTS PRESENTING WITH CHEST PAIN THAT ARE AT RISK...". FDA records list one 510(k) clearance for Prognostix, Inc. As of , FDA records show no recalls naming K050029.

Clearance record

Decision date
Received
(124 days to decision)
Product code
NTV Myeloperoxidase, Immunoassay, System, Test
Regulation
21 CFR 866.5600
Device class
Class II
Review panel
Immunology
Applicant
Prognostix, Inc. 10265 Carnegie Ave., Cleveland OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NTV

Trailing 12 months

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

FDA records show no clearances under product code NTV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NTV, 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