Cleared Traditional

K881259 - MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881259 · Triton Biosciences, Inc. · Pathology device
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Oct 1988
Decision
203d
Days
Class 2
Risk

K881259 is an FDA 510(k) clearance for the MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL. Classified as Cytokeratins (product code LYE), Class II - Special Controls.

Submitted by Triton Biosciences, Inc. (Alameda, US). The FDA issued a Cleared decision on October 12, 1988 after a review of 203 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.5550 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Triton Biosciences, Inc. devices

Submission Details

510(k) Number K881259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1988
Decision Date October 12, 1988
Days to Decision 203 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 77d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LYE Cytokeratins
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 Pathology devices follow this clearance model.