Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

MHJ — Predicate Candidate Screening

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

141 daysmedian FDA review time

307 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K171078	TRI-COMBO PARASITE SCREEN	Techlab, Inc.	2017-07-10	90	0
K121565	UNI-GOLD CRYPTOSPORIDIUM	Trinity Biotech	2013-02-08	255	0
K051929	GIARDIA/CRYPTOSPORIDIUM CHEK	Techlab, Inc.	2005-11-17	127	0
K052932	CRYPTOSPORIDIUM II	Techlab, Inc.	2005-11-04	16	0
K031965	XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020	Remel, Inc.	2003-11-14	141	1
K031059	IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96	Ivd Research, Inc.	2003-07-10	104	0
K982764	PREMIER CRYPTOSPORIDIUM	Meridian Diagnostics, Inc.	1998-12-03	119	0
K982709	MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY	Alexon - Trend, Inc.	1998-09-03	30	0
K980354	CRYPTOSPORIDIUM TEST	Techlab, Inc.	1998-05-18	109	0
K955852	CRYPTO-CEL IF TEST	Techlab, Inc.	1996-08-05	223	0
K955755	TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS	Trend Scientific, Inc.	1996-07-11	204	0
K955345	LMD CRYPTOSPORIDIUM ANTIGEN DETECTION	Lmd Laboratories	1996-06-07	199	0
K936191	PROSPECT CRYPTOSPORIDIUM RAPID ASSAY	Alexon Biomedical, Inc.	1994-11-17	329	0
K912242	PROSPECT(TM/CRYPTOSPORIDIUM	Alexon, Inc.	1992-03-23	307	0
K905598	CRYPTOSPORIDIUM ANTIGEN DETECTION	Lmd Laboratories	1991-09-05	266	0

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