Cleared Traditional

K964368 - ELECSYS CEA ASSAY

K964368 is an FDA 510(k) clearance for ELECSYS CEA ASSAY, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Immunology device with product code JIT cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K964368 · Boehringer Mannheim Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
227d
Days
Class 2
Risk

K964368 is an FDA 510(k) clearance for the ELECSYS CEA ASSAY. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on June 16, 1997 after a review of 227 days - an extended review cycle.

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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K964368

510(k) Number K964368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1996
Decision Date June 16, 1997
Days to Decision 227 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
123d slower than avg
Panel avg: 104d · This submission: 227d
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 173
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K964368.
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