Cleared Special

K003967 - CA 125 II CALCHECK

K003967 is the FDA 510(k) clearance for CA 125 II CALCHECK by Roche Diagnostics Corp.. It is a Class 1 Immunology device (product code JJX) cleared through the Special 510(k) pathway after a 21-day FDA review.

K003967 · Roche Diagnostics Corp. · Immunology device
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Jan 2001
Decision
21d
Days
Class 1
Risk

K003967 is an FDA 510(k) clearance for the CA 125 II CALCHECK. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General 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 862.1660 - 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.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K003967 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
83d faster than avg
Panel avg: 104d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 268
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K003967.
VIGIL DNASE B CONTROL
K010693 · Beckman Coulter, Inc. · Apr 2001
ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
K010428 · Beckman Coulter, Inc. · Mar 2001
ELECSYS HCG+B CALCHECK
K010237 · Roche Diagnostics Corp. · Feb 2001
ELECSYS DHEA-S CALCHECK
K003772 · Roche Diagnostics Corp. · Dec 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
K003112 · Ortho-Clinical Diagnostics, Inc. · Nov 2000
SUGAR CHEX ONE
K001443 · Streck Laboratories, Inc. · Jun 2000