Cleared Special

K003969 - ELECSYS CA 125 II CALSET

K003969 is an FDA 510(k) clearance for ELECSYS CA 125 II CALSET, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Immunology device with product code JIS cleared through the Special 510(k) pathway after a 21-day FDA review.

K003969 · Roche Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
21d
Days
Class 2
Risk

K003969 is an FDA 510(k) clearance for the ELECSYS CA 125 II 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 January 12, 2001 after a review of 21 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K003969

510(k) Number K003969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2000
Decision Date January 12, 2001
Days to Decision 21 days
Submission Type Special
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
84d faster than avg
Panel avg: 105d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

JIS Device Classification - Class 2, Special Controls

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 120
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K003969.
RANDOX LIPOPROTEIN
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BECKMAN COULTER DNASE B CALIBRATOR
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ELECSYS HCG STAT CLASET II
K003941 · 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
ELECSYS INSULIN CALSET
K001906 · Roche Diagnostics Corp. · Jul 2000
K003969 · ELECSYS CA 125 II CALSET
Download PDF FDA Summary Roche Diagnostics Cor…