Cleared Traditional

K003941 - ELECSYS HCG STAT CLASET II

K003941 is the FDA 510(k) clearance for ELECSYS HCG STAT CLASET II by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K003941 · Roche Diagnostics Corp. · Chemistry device
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Jan 2001
Decision
35d
Days
Class 2
Risk

K003941 is an FDA 510(k) clearance for the ELECSYS HCG STAT CLASET II. 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 January 25, 2001 after a review of 35 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 K003941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2000
Decision Date January 25, 2001
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
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 K003941.
N LP(A) STANDARD SY
K013126 · Dade Behring, Inc. · Nov 2001
RANDOX LIPOPROTEIN
K011568 · Randox Laboratories, Ltd. · Sep 2001
BECKMAN COULTER DNASE B CALIBRATOR
K010696 · Beckman Coulter, Inc. · May 2001
ELECSYS CA 125 II CALSET
K003969 · Roche Diagnostics Corp. · Jan 2001
ELECSYS DHEA-S CALSET
K002760 · Roche Diagnostics Corp. · Oct 2000
ELECSYS CA 15-3 CALCHECK
K002353 · Roche Diagnostics Corp. · Aug 2000