Cleared Traditional

K894081 - ROCHO ISOMUNE - LD

K894081 is the FDA 510(k) clearance for ROCHO ISOMUNE - LD by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CFE) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K894081 · Roche Diagnostic Systems, Inc. · Chemistry device
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Aug 1989
Decision
84d
Days
Class 2
Risk

K894081 is an FDA 510(k) clearance for the ROCHO ISOMUNE - LD. Classified as Electrophoretic, Lactate Dehydrogenase Isoenzymes (product code CFE), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on August 31, 1989 after a review of 84 days - a notably fast clearance 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: 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K894081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1989
Decision Date August 31, 1989
Days to Decision 84 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
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFE Electrophoretic, 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 - CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes

All 19
Devices cleared under the same product code (CFE) and FDA review panel - the closest regulatory comparables to K894081.
CARDIO REP LD
K940224 · Helena Laboratories · Aug 1994
ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD
K921455 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1992
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH
K905861 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1991
REP(TM) LD-2 STAT KIT, CAT. NO. 3078
K892818 · Helena Laboratories · Jun 1989
TITAN GEL REP LDH-30 HV
K874142 · Helena Laboratories · Nov 1987
TITAN GEL REP LDH-6 HV
K874145 · Helena Laboratories · Nov 1987