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510(k) K232898

Quantisal™ Oral Fluid Collection Device by Immunalysis Corporation — Product Code PJD

K232898 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "Quantisal™ Oral Fluid Collection Device". The FDA issued a decision of Substantially Equivalent on November 21, 2023. 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. Immunalysis Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2023
Date Received
September 18, 2023
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 Immunalysis Corporation

  • K252520 — SEFRIA™ Hydrocodone Oral Fluid (September 11, 2025)
  • K223781 — Quantisal™ II Oral Fluid Collection Device (July 28, 2023)
  • K203564 — SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay (December 22, 2021)
  • K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (December 22, 2021)
  • K203489 — SEFRIA PCP Oral Fluid Enzyme Immunoassay (April 20, 2021)
  • K200801 — Quantisal Oral Fluid Collection Device (July 28, 2020)
  • K190397 — Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA (November 15, 2019)
  • K183048 — Quantisal II Oral Fluid Collection Device (July 29, 2019)
  • K181135 — Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (January 24, 2019)
  • K181553 — Immunalysis Ethyl Alcohol Enzyme Assay (October 31, 2018)

Other clearances for product code PJD

  • 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)
  • K011057 — INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX (June 6, 2001)
  • 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