Cleared Traditional

SPOTCHEM II LDH TEST (K050790) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050790 · Arkray, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
70d
Days
Class 2
Risk

K050790 is an FDA 510(k) clearance for the SPOTCHEM II LDH TEST. Classified as Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase (product code CFH), Class II - Special Controls.

Submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on June 6, 2005 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1440 - 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

Submission Details

510(k) Number K050790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2005
Decision Date June 06, 2005
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFH Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1440
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 - CFH Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase

Devices cleared under the same product code (CFH) and FDA review panel - the closest regulatory comparables to K050790.
CLINISTAT LDH REAGENT TEST
K895138 · Heraeus Kulzer, Inc. · Oct 1989
IQ LDH
K894578 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1989
EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE
K852391 · Helena Laboratories · Oct 1985
WAKO LDH CII TEST
K842452 · Wako Chemicals USA, Inc. · Aug 1984