Cleared Traditional

K002760 - ELECSYS DHEA-S CALSET

K002760 is the FDA 510(k) clearance for ELECSYS DHEA-S CALSET by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K002760 · Roche Diagnostics Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Oct 2000
Decision
30d
Days
Class 2
Risk

K002760 is an FDA 510(k) clearance for the ELECSYS DHEA-S CALSET. 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 October 5, 2000 after a review of 30 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K002760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2000
Decision Date October 05, 2000
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
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 Chemistry 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 K002760.
BECKMAN COULTER DNASE B CALIBRATOR
K010696 · Beckman Coulter, Inc. · May 2001
ELECSYS HCG STAT CLASET II
K003941 · Roche Diagnostics Corp. · Jan 2001
ELECSYS CA 125 II CALSET
K003969 · Roche Diagnostics Corp. · Jan 2001
ELECSYS CA 15-3 CALCHECK
K002353 · Roche Diagnostics Corp. · Aug 2000
ELECSYS INSULIN CALSET
K001906 · Roche Diagnostics Corp. · Jul 2000
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
K001004 · Wako Chemicals USA, Inc. · Jun 2000