510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123986Substantially Equivalent

Actim Prom

Alere Scarborough, Inc., Scarborough ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123986 is the FDA 510(k) clearance record for ACTIM PROM, a class I device, cleared for Alere Scarborough, Inc. 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 17 510(k) clearances for Alere Scarborough, Inc., from to . As of , FDA records show one recall naming K123986.

Clearance record

Decision date
Received
(379 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
Alere Scarborough, Inc. 10 Southgate Rd., Scarborough ME
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