510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011057Substantially Equivalent

Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-Xxxx

OraSure Technologies, Inc., Bethlehem PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011057 is the FDA 510(k) clearance record for INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX, a class II device, cleared for OraSure Technologies, Inc. on under FDA product code PJD (Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device). FDA's definition for product code PJD reads: "Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing". FDA records list 30 510(k) clearances for OraSure Technologies, Inc., from to . As of , FDA records show no recalls naming K011057.

Clearance record

Decision date
Received
(61 days to decision)
Product code
PJD Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
OraSure Technologies, Inc. 150 Webster St., Bethlehem PA
510(k) summary
Summary
Third party review
No

Clearances, product code PJD

Trailing 12 months

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

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