Cleared Traditional

K051927 - TECHLAB ASCA-CHEK

K051927 is the FDA 510(k) clearance for TECHLAB ASCA-CHEK by Techlab, Inc.. It is a Class 2 Immunology device (product code NBT) cleared through the Traditional 510(k) pathway after a 262-day FDA review.

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

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

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on April 6, 2006 after a review of 262 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5785 - 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. Standard predicate reliance. 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 Techlab, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 104d · 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.

Regulatory Peers - NBT Antibodies, Saccharomyces Cerevisiae (s.cerevisiae)

Devices cleared under the same product code (NBT) and FDA review panel - the closest regulatory comparables to K051927.
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
K032850 · Immco Diagnostics, Inc. · Mar 2004
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)
K032860 · Immco Diagnostics, Inc. · Mar 2004
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
K000733 · Inova Diagnostics, Inc. · May 2001
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
DEN000007 · Inova Diagnostics, Inc. · Aug 2000