Cleared Traditional

K881259 - MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL

K881259 is an FDA 510(k) clearance for MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL, manufactured by Triton Biosciences, Inc.. The device is a Class 2 Pathology device with product code LYE cleared through the Traditional 510(k) pathway after a 203-day FDA review.

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.

FDA 510(k) Submission Details - K881259

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
125d slower than avg
Panel avg: 78d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYE Device Classification - Class 2, Special Controls

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.