Cleared Special

K071971 - DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATI...

K071971 is an FDA 510(k) clearance for DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATI..., manufactured by Diazyme Laboratories. The device is a Class 2 Chemistry device with product code LPS cleared through the Special 510(k) pathway after a 62-day FDA review.

K071971 · Diazyme Laboratories · Chemistry device
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Sep 2007
Decision
62d
Days
Class 2
Risk

K071971 is an FDA 510(k) clearance for the DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S).... Classified as Urinary Homocystine (nonquantitative) Test System (product code LPS), Class II - Special Controls.

Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on September 17, 2007 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1377 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Diazyme Laboratories devices

FDA 510(k) Submission Details - K071971

510(k) Number K071971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2007
Decision Date September 17, 2007
Days to Decision 62 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

LPS Device Classification - Class 2, Special Controls

Product Code LPS Urinary Homocystine (nonquantitative) Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1377
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LPS Urinary Homocystine (nonquantitative) Test System

All 20
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