Cleared Traditional

K051927 - TECHLAB ASCA-CHEK (FDA 510(k) Clearance)

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

K051927 · Techlab, Inc. · Immunology device
Apr 2006
Decision
262d
Days
Class 2
Risk

K051927 is an FDA 510(k) clearance for the TECHLAB ASCA-CHEK. This device is classified as a Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) (Class II - Special Controls, product code NBT).

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on April 6, 2006, 262 days after receiving the submission on July 18, 2005.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5785.

Submission Details

510(k) Number K051927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2005
Decision Date April 06, 2006
Days to Decision 262 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 277d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBT Antibodies, Saccharomyces Cerevisiae (s.cerevisiae)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5785
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.