Cleared Traditional

K950149 - CHEMMATE(TM) LAMBDA

K950149 is an FDA 510(k) clearance for CHEMMATE(TM) LAMBDA, manufactured by Biotek Solutions, Inc.. The device is a Class 2 Immunology device with product code DEH cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K950149 · Biotek Solutions, Inc. · Immunology device
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Dec 1995
Decision
323d
Days
Class 2
Risk

K950149 is an FDA 510(k) clearance for the CHEMMATE(TM) LAMBDA. Classified as Lambda, Antigen, Antiserum, Control (product code DEH), Class II - Special Controls.

Submitted by Biotek Solutions, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on December 6, 1995 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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. Elevated predicate reliance profile. 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 Biotek Solutions, Inc. devices

FDA 510(k) Submission Details - K950149

510(k) Number K950149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1995
Decision Date December 06, 1995
Days to Decision 323 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
218d slower than avg
Panel avg: 105d · This submission: 323d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEH Device Classification - Class 2, Special Controls

Product Code DEH Lambda, Antigen, Antiserum, Control
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 Immunology devices follow this clearance model.

Regulatory Peers - DEH Lambda, Antigen, Antiserum, Control

All 46
Devices cleared under the same product code (DEH) and FDA review panel - the closest regulatory comparables to K950149.
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