Cleared Traditional

K140112 - CA 125 II CALSET II

K140112 is an FDA 510(k) clearance for CA 125 II CALSET II, manufactured by Roche Diagnostics. The device is a Class 2 Immunology device with product code JIT cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K140112 · Roche Diagnostics · Immunology device
Download Printable Device Report (PDF)
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Jun 2014
Decision
142d
Days
Class 2
Risk

K140112 is an FDA 510(k) clearance for the CA 125 II CALSET II. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on June 6, 2014 after a review of 142 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostics devices

FDA 510(k) Submission Details - K140112

510(k) Number K140112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2014
Decision Date June 06, 2014
Days to Decision 142 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
37d slower than avg
Panel avg: 105d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
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 - JIT Calibrator, Secondary

All 203
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K140112.
RANDOX ALDOLASE CALIBRATION SERUM
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DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
K133751 · Diamond Diagnostics, Inc. · Aug 2014
ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
K140648 · Tosoh Bioscience, Inc. · Apr 2014
LP(A) CALIBRATORS, AND LP(A) CONTROLS
K132400 · Biokit, S.A. · Dec 2013
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
K131556 · Diazyme Laboratories · Jun 2013