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510(k) K011057

INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX by OraSure Technologies, Inc. — Product Code PJD

K011057 is an FDA 510(k) premarket notification submitted by OraSure Technologies, Inc. for the device "INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX". The FDA issued a decision of Substantially Equivalent on June 6, 2001. The device falls under product code PJD (Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device), a Class II device regulated under 21 CFR 862.1675. OraSure Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2001
Date Received
April 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.

Other clearances by OraSure Technologies, Inc.

  • DEN190025 — OraQuick Ebola Rapid Antigen Test (October 10, 2019)
  • K060859 — COMPOUND W FREEZE OFF WART REMOVAL SYSTEM (July 18, 2006)
  • K023487 — HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME (March 20, 2003)
  • K013882 — OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I (April 17, 2002)
  • K020371 — UPLINK TEST SYSTEM (April 3, 2002)
  • K002375 — STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I (January 26, 2001)
  • K001976 — STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I (December 6, 2000)
  • K002010 — STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 (November 29, 2000)
  • K000399 — STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 (May 15, 2000)
  • K001197 — COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA (May 11, 2000)

Other clearances for product code PJD

  • K232898 — Quantisal™ Oral Fluid Collection Device (November 21, 2023)
  • K223781 — Quantisal™ II Oral Fluid Collection Device (July 28, 2023)
  • K200801 — Quantisal Oral Fluid Collection Device (July 28, 2020)
  • K183048 — Quantisal II Oral Fluid Collection Device (July 29, 2019)
  • K984361 — ORAL-EZE ORAL FLUID COLLECTION SYSTEM (January 13, 1999)
  • K973395 — EPISCREEN ORAL SPECIMEN COLLECTION DEVICE (February 13, 1998)
  • K970357 — EPISCREEN (March 10, 1997)
  • K942435 — SALIVA SAMPLER (August 21, 1995)

FDA data resources