Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Immunalysis Corporation — Predicate Candidate Screening

50 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

82 daysmedian FDA review time

269 days90th percentile

50clearances measured

K-number	Device	Applicant	Decided	Review days
K252520	SEFRIA™ Hydrocodone Oral Fluid	Immunalysis Corporation	2025-09-11	31
K232898	Quantisal™ Oral Fluid Collection Device	Immunalysis Corporation	2023-11-21	64
K223781	Quantisal™ II Oral Fluid Collection Device	Immunalysis Corporation	2023-07-28	224
K203564	SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay	Immunalysis Corporation	2021-12-22	380
K203647	SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay	Immunalysis Corporation	2021-12-22	373
K203489	SEFRIA PCP Oral Fluid Enzyme Immunoassay	Immunalysis Corporation	2021-04-20	144
K200801	Quantisal Oral Fluid Collection Device	Immunalysis Corporation	2020-07-28	123
K190397	Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA	Immunalysis Corporation	2019-11-15	269
K183048	Quantisal II Oral Fluid Collection Device	Immunalysis Corporation	2019-07-29	269
K181135	Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay	Immunalysis Corporation	2019-01-24	269
K181553	Immunalysis Ethyl Alcohol Enzyme Assay	Immunalysis Corporation	2018-10-31	140
K161216	Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immuna	Immunalysis Corporation	2017-06-14	411
K161714	Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalys	Immunalysis Corporation	2016-10-14	115
K153693	Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immuna	Immunalysis Corporation	2016-03-18	86
K151771	Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immuna	Immunalysis Corporation	2016-01-05	189
K152176	Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-	Immunalysis Corporation	2015-09-04	31
K151395	Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunaly	Immunalysis Corporation	2015-07-24	59
K150925	Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immuna	Immunalysis Corporation	2015-06-29	84
K151203	Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalys	Immunalysis Corporation	2015-06-05	31
K143502	Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Op	Immunalysis Corporation	2015-05-20	161
K150275	Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immun	Immunalysis Corporation	2015-03-09	33
K141803	IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY	Immunalysis Corporation	2015-02-12	224
K143500	Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysi	Immunalysis Corporation	2015-02-06	58
K141406	IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALY	Immunalysis Corporation	2014-07-01	34
K131168	IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY	Immunalysis Corporation	2014-01-17	268
K051578	IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS	Immunalysis Corporation	2005-11-18	157
K051579	IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS	Immunalysis Corporation	2005-10-21	129
K051626	IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS	Immunalysis Corporation	2005-10-13	115
K051577	IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS	Immunalysis Corporation	2005-10-04	112
K050465	IMMUNALYSIS COCAINE ELISA FOR HAIR	Immunalysis Corporation	2005-08-04	154
K933572	URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)	Immunalysis Corporation	1994-04-06	257
K913864	PCP DIRECT RIA KIT (I-125)	Immunalysis Corporation	1991-10-11	45
K913866	URINE AMPHETAMINE DIRECT RIA KIT (I-125)	Immunalysis Corporation	1991-09-25	29
K913867	URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)	Immunalysis Corporation	1991-09-19	23
K913863	URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)	Immunalysis Corporation	1991-09-19	23
K913865	URINE THC DIRECT RIA KIT (I-125)	Immunalysis Corporation	1991-09-18	22
K871549	RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]	Immunalysis Corporation	1987-06-16	63
K871698	RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]	Immunalysis Corporation	1987-06-15	48
K843534	ORAL THC-CANNABINOIDS DIRECT RIA KIT	Immunalysis Corporation	1984-10-30	53
K833911	URINE THC CANNABINOIDS DIRECT RIA KIT	Immunalysis Corporation	1984-01-24	71
K821965	ORAL THC-CANNABINOIDS DIRECT RIA KIT	Immunalysis Corporation	1982-07-20	18
K820903	THC-CANNABINOIDS DIRECT URINE RIA KIT	Immunalysis Corporation	1982-05-05	35
K811906	DHEA-SULFATE DIRECT RIA KIT(125I)	Immunalysis Corporation	1981-07-23	22
K811907	PROGESTERONE DIRECT RIA KIT (125I)	Immunalysis Corporation	1981-07-23	22
K811905	FOLLICLE STIMULATING HORMONE DIRECT RIA	Immunalysis Corporation	1981-07-23	22
K811024	LUTEINIZING HORMONE DIRECT RIA KIT 125/I	Immunalysis Corporation	1981-05-08	23
K800514	PHENCYCLIDINE DIRECT BLOOD RIA KIT	Immunalysis Corporation	1980-03-19	14
K791649	TETRAHYDROCANNALBINOL DIRECT BLOOD KIT	Immunalysis Corporation	1979-10-11	48
K781546	DIRECT ESTRIOL RIA KIT	Immunalysis Corporation	1978-12-04	82
K781048	THC DIRECT RIA KIT	Immunalysis Corporation	1978-10-03	104

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda