Cleared Traditional

K071711 - ASCA-CHEK

K071711 is an FDA 510(k) clearance for ASCA-CHEK, manufactured by Techlab Inc., Corporate Research Center. The device is a Class 2 Immunology device with product code NBT cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K071711 · Techlab Inc., Corporate Research Center · Immunology device
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Nov 2007
Decision
138d
Days
Class 2
Risk

K071711 is an FDA 510(k) clearance for the ASCA-CHEK. Classified as Antibodies, Saccharomyces Cerevisiae (s.cerevisiae) (product code NBT), Class II - Special Controls.

Submitted by Techlab Inc., Corporate Research Center (Blacksburg, US). The FDA issued a Cleared decision on November 7, 2007 after a review of 138 days - within the typical 510(k) review window.

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., Corporate Research Center devices

FDA 510(k) Submission Details - K071711

510(k) Number K071711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2007
Decision Date November 07, 2007
Days to Decision 138 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
33d slower than avg
Panel avg: 105d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBT Device Classification - Class 2, Special Controls

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)

All 7
Devices cleared under the same product code (NBT) and FDA review panel - the closest regulatory comparables to K071711.
TECHLAB ASCA-CHEK
K051927 · Techlab, Inc. · Apr 2006
AESKULISA ASCA A
K051492 · Aesku, Inc. · Nov 2005
BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
K042579 · The Binding Site · Jul 2005
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