Cleared Traditional

K042443 - SPOTCHEM HDL

K042443 is an FDA 510(k) clearance for SPOTCHEM HDL, manufactured by Arkray, Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K042443 · Arkray, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
76d
Days
Class 1
Risk

K042443 is an FDA 510(k) clearance for the SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on November 24, 2004 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arkray, Inc. devices

FDA 510(k) Submission Details - K042443

510(k) Number K042443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2004
Decision Date November 24, 2004
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 88d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

CHH Device Classification - Class 1, General Controls

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CHH Enzymatic Esterase--oxidase, Cholesterol

All 141
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K042443.
EASYRA CHOLESTEROL REAGENT
K072249 · Medica Corp. · Feb 2008
PTS PANELS CHOL+HDL PANEL TEST STRIPS
K071593 · Polymer Technology Systems, Inc. · Oct 2007
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE
K051376 · Roche Diagnostics · Aug 2005
COBAS INTEGRA CHOLESTEROL GEN. 2
K031824 · Roche Diagnostics Corp. · Jul 2003
PTS PANELS LIPID PANEL TEST STRIPS
K023558 · Polymer Technology Systems, Inc. · Nov 2002
PTS PANELS LIPID PANEL TEST STRIPS
K022898 · Polymer Technology Systems, Inc. · Sep 2002