510(k) Report

FDA applicant

Immunalysis Corporation

Pomona, CA50 decisions1978–20251 recall

FDA records 50 decisions for Immunalysis Corporation (Pomona, CA) from 1978 to 2025: 50 510(k) clearances. Most are in product codes DJG (Enzyme Immunoassay, Opiates) and LAT (Radioimmunoassay, Cannabinoid (S)). Since 2016 its 510(k)s took a median of 380 days from receipt to decision, against 101 for FDA’s reviews in the same codes and years. Its devices cite 29 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical toxicology panel, where it files most

How often FDA has decided Immunalysis Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2014: 22015: 82016: 32017: 12018: 12019: 32020: 12021: 32023: 22025: 1
2007high 8 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Immunalysis Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Immunalysis Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DJGEnzyme Immunoassay, Opiates11decisions
  • LATRadioimmunoassay, Cannabinoid (S)7decisions
  • PJDOral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device4decisions
  • LAFGas Chromatography, Methamphetamine3decisions
  • DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites3decisions
  • LCMEnzyme Immunoassay, Phencyclidine3decisions

Also: LCL (2), DKZ (2), KLN (2), CEP (1), LDJ (1), DJR (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 380 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 101 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 29 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K161216Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine CalibratorsImmunalysis Corporation · 20172cite it
  • K151395Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP…Immunalysis Corporation · 20152cite it
  • K183048Quantisal II Oral Fluid Collection DeviceImmunalysis Corporation · 20192cite it
  • K141803Immunalysis Tramadol Urine Enzyme ImmunoassayImmunalysis Corporation · 20151cites it
  • K203564SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 20211cites it
  • K181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 20191cites it

What has FDA decided for it lately?

  • K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis Corporation · 2025
  • K232898Quantisal™ Oral Fluid Collection DeviceImmunalysis Corporation · 2023
  • K223781Quantisal™ II Oral Fluid Collection DeviceImmunalysis Corporation · 2023
  • K203564SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
  • K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
  • K203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
  • K200801Quantisal Oral Fluid Collection DeviceImmunalysis Corporation · 2020
  • K190397Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIAImmunalysis Corporation · 2019

All 50 as Immunalysis Corporation →

What has been recalled?

1 recall linked to its devices; the latest:

  • K151395lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75…Nov 28, 2017Class III