Product Code: MHJ FDA class 2 21 CFR 866.3220

Cryptosporidium Spp.

Microbiology

The Cryptosporidium Spp. device is an in vitro diagnostic test used to detect Cryptosporidium species, parasitic protozoa that cause cryptosporidiosis, a gastrointestinal infection associated with contaminated water or food, in patient specimens. Classified as Class 2 under 21 CFR 866.3220 governing serological reagents, it requires 510(k) premarket notification to establish substantial equivalence to a legally marketed predicate device. It falls within the Microbiology specialty and is subject to general and special controls. It does not carry implant or life-sustaining flags.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: MHJ
Device Class: FDA class 2
Regulation Number: 866.3220
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 15 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K171078	TRI-COMBO PARASITE SCREEN	Jul 10, 2017	Substantially Equivalent	Techlab, Inc.
K121565	UNI-GOLD CRYPTOSPORIDIUM	Feb 08, 2013	Substantially Equivalent	Trinity Biotech
K051929	GIARDIA/CRYPTOSPORIDIUM CHEK	Nov 17, 2005	Substantially Equivalent	Techlab, Inc.
K052932	CRYPTOSPORIDIUM II	Nov 04, 2005	Substantially Equivalent	Techlab, Inc.
K031965	XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020	Nov 14, 2003	Substantially Equivalent	Remel, Inc.
K031059	IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96	Jul 10, 2003	Substantially Equivalent	Ivd Research, Inc.
K982764	PREMIER CRYPTOSPORIDIUM	Dec 03, 1998	Substantially Equivalent	Meridian Diagnostics, Inc.
K982709	MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY	Sep 03, 1998	Substantially Equivalent	Alexon - Trend, Inc.
K980354	CRYPTOSPORIDIUM TEST	May 18, 1998	Substantially Equivalent	Techlab, Inc.
K955852	CRYPTO-CEL IF TEST	Aug 05, 1996	Substantially Equivalent	Techlab, Inc.
K955755	TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS	Jul 11, 1996	Substantially Equivalent	Trend Scientific, Inc.
K955345	LMD CRYPTOSPORIDIUM ANTIGEN DETECTION	Jun 07, 1996	Substantially Equivalent	Lmd Laboratories
K936191	PROSPECT CRYPTOSPORIDIUM RAPID ASSAY	Nov 17, 1994	Substantially Equivalent	Alexon Biomedical, Inc.
K912242	PROSPECT(TM/CRYPTOSPORIDIUM	Mar 23, 1992	Substantially Equivalent	Alexon, Inc.
K905598	CRYPTOSPORIDIUM ANTIGEN DETECTION	Sep 05, 1991	Substantially Equivalent	Lmd Laboratories