Cleared Traditional

K002353 - ELECSYS CA 15-3 CALCHECK

K002353 is the FDA 510(k) clearance for ELECSYS CA 15-3 CALCHECK by Roche Diagnostics Corp.. It is a Class 2 Immunology device (product code JIS) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K002353 · Roche Diagnostics Corp. · Immunology device
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Aug 2000
Decision
8d
Days
Class 2
Risk

K002353 is an FDA 510(k) clearance for the ELECSYS CA 15-3 CALCHECK. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 10, 2000 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - the FDA immunology device 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 Diagnostics Corp. devices

Submission Details

510(k) Number K002353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2000
Decision Date August 10, 2000
Days to Decision 8 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 104d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
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 Immunology devices follow this clearance model.

Regulatory Peers - JIS Calibrator, Primary

All 69
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K002353.
ELECSYS HCG STAT CLASET II
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ELECSYS INSULIN CALSET
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