Cleared Traditional

GEMENI CK-MB ISOENZYME ABNORMAL SERUM (K810870) - FDA 510(k) Clearance

Class I Chemistry device.

K810870 · Gemini, Inc. · Chemistry device
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Apr 1981
Decision
14d
Days
Class 1
Risk

K810870 is an FDA 510(k) clearance for the GEMENI CK-MB ISOENZYME ABNORMAL SERUM. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Gemini, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1981 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Gemini, Inc. devices

Submission Details

510(k) Number K810870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1981
Decision Date April 14, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJT Enzyme Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJT Enzyme Controls (assayed And Unassayed)

All 31
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K810870.
ID-ZONE LD ISOENZYME CONTROL
K822984 · Beckman Instruments, Inc. · Nov 1982
QUANTAPHOS ACID PHOSPHATOSE CONT. SERUM
K822646 · Beckman Instruments, Inc. · Sep 1982
TITAN GEL CPK/LDH ISOENZYME CONTROL
K821981 · Helena Laboratories · Jul 1982
DUPONT 'ACA' CREATINE KINASE VERIFIERS
K803305 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1981
CK ISOENZYME ELECTROPHORESIS CONTROL-I.D
K800604 · Beckman Instruments, Inc. · Apr 1980
DELTA TEST AMYLASE/LIPASE CONTS. I,II
K781100 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1978