Cleared Traditional

K821983 - TITAN GEL LDH ISOENZYME KIT

K821983 is an FDA 510(k) clearance for TITAN GEL LDH ISOENZYME KIT, manufactured by Helena Laboratories. The device is a Class 2 Chemistry device with product code CEX cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K821983 · Helena Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1982
Decision
169d
Days
Class 2
Risk

K821983 is an FDA 510(k) clearance for the TITAN GEL LDH ISOENZYME KIT. Classified as Chromatographic Separation, Lactate Dehydrogenase Isoenzymes (product code CEX), Class II - Special Controls.

Submitted by Helena Laboratories (Walker, US). The FDA issued a Cleared decision on December 22, 1982 after a review of 169 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1445 - 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.

FDA 510(k) Submission Details - K821983

510(k) Number K821983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1982
Decision Date December 22, 1982
Days to Decision 169 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 89d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEX Device Classification - Class 2, Special Controls

Product Code CEX Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1445
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 - CEX Chromatographic Separation, Lactate Dehydrogenase Isoenzymes

All 7
Devices cleared under the same product code (CEX) and FDA review panel - the closest regulatory comparables to K821983.
LACTATE DEHYDROGENASE ISOENZYME 1
K872891 · Data Medical Associates, Inc. · Sep 1987
LD-1(IMMUNO) SEPARATION SET
K851521 · Seragen Diagnostics, Inc. · May 1985
ISO-SEP SYSTEM
K842018 · Berwick Medical Products, Inc. · Sep 1984
ULTRACHEM T.P.
K821879 · Harleco Diagnostics · Jul 1982
CENTRIFICHEM CREATININE
K800129 · Union Carbide Corp. · Feb 1980
LDH ISOENZYME COLUMN REAGENT SET
K772356 · Worthington Biochemical Corp. · Jan 1978
K821983 · TITAN GEL LDH ISOENZYME KIT
Download PDF Helena Laboratories