510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K061886Substantially Equivalent

Actim Prom and Controls

Medix Biochemica, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061886 is the FDA 510(k) clearance record for ACTIM PROM AND CONTROLS, a class I device, cleared for Medix Biochemica on under FDA product code OAM (Immunoassay, Insulin-Like Growth Factor Binding Protein-1). FDA's definition for product code OAM reads: "The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions. The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women". FDA records list one 510(k) clearance for Medix Biochemica. As of , FDA records show no recalls naming K061886.

Clearance record

Decision date
Received
(206 days to decision)
Product code
OAM Immunoassay, Insulin-Like Growth Factor Binding Protein-1
Regulation
21 CFR 862.1550
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Medix Biochemica 49 Plain St., North Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OAM

Trailing 12 months

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

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