Cleared Traditional

K121053 - DIAZYME HOMOCYSTEINE POC TEST KIT

K121053 is an FDA 510(k) clearance for DIAZYME HOMOCYSTEINE POC TEST KIT, manufactured by Diazyme Laboratories. The device is a Class 2 Chemistry device with product code LPS cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K121053 · Diazyme Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
116d
Days
Class 2
Risk

K121053 is an FDA 510(k) clearance for the DIAZYME HOMOCYSTEINE POC TEST KIT. 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 July 31, 2012 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1377 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diazyme Laboratories devices

FDA 510(k) Submission Details - K121053

510(k) Number K121053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2012
Decision Date July 31, 2012
Days to Decision 116 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 88d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (LPS) and FDA review panel - the closest regulatory comparables to K121053.
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
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ST AIA-PACK HOMOCYSTEINE
K121533 · Tosoh Bioscience, Inc. · Jun 2012
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K112790 · Axis-Shield Diagnostics, Ltd. · May 2012
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
K083222 · Axis-Shield Diagnostics, Ltd. · Jul 2009
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
K073640 · Axis-Shield Diagnostics, Ltd. · Apr 2008
DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL
K071971 · Diazyme Laboratories · Sep 2007