Cleared Traditional

K953927 - LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM

K953927 is an FDA 510(k) clearance for LINICAL PROTEIN VI CALIBRATION VERIFIER..., manufactured by International Enzymes, Inc.. The device is a Class 2 Immunology device with product code DCF cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K953927 · International Enzymes, Inc. · Immunology device
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Sep 1995
Decision
31d
Days
Class 2
Risk

K953927 is an FDA 510(k) clearance for the LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN.... Classified as Albumin, Antigen, Antiserum, Control (product code DCF), Class II - Special Controls.

Submitted by International Enzymes, Inc. (San Marcos, US). The FDA issued a Cleared decision on September 15, 1995 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5040 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all International Enzymes, Inc. devices

FDA 510(k) Submission Details - K953927

510(k) Number K953927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1995
Decision Date September 15, 1995
Days to Decision 31 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 105d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCF Device Classification - Class 2, Special Controls

Product Code DCF Albumin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5040
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 - DCF Albumin, Antigen, Antiserum, Control

All 35
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K953927.
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