Cleared Traditional

REAGENTS FOR COBAS ISE MODULE (K934701) - FDA 510(k) Clearance

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

K934701 · Alko Diagnostic Corp. · Chemistry device
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Dec 1993
Decision
63d
Days
Class 2
Risk

K934701 is an FDA 510(k) clearance for the REAGENTS FOR COBAS ISE MODULE. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Alko Diagnostic Corp. (Holliston, US). The FDA issued a Cleared decision on December 2, 1993 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Alko Diagnostic Corp. devices

Submission Details

510(k) Number K934701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1993
Decision Date December 02, 1993
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 85
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K934701.
ROCHE CALIBRATOR SERUM
K942706 · Roche Diagnostic Systems, Inc. · Sep 1995
ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR
K952282 · Roche Diagnostic Systems, Inc. · Sep 1995
ACA PLUS FERRITIN CALIBRATOR
K935543 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1994
CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323
K932768 · Helena Laboratories · Oct 1993
SIGMA CX-3 CALIBRATION STANDARD LEVEL 2
K933693 · Sigma Chemical Co. · Oct 1993
DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM
K933955 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1993