Cleared Traditional

K001022 - BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061

K001022 is an FDA 510(k) clearance for BIOCHECK, manufactured by Biocheck, Inc.. The device is a Class 2 Immunology device with product code JZG cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K001022 · Biocheck, Inc. · Immunology device
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Sep 2000
Decision
180d
Days
Class 2
Risk

K001022 is an FDA 510(k) clearance for the BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Biocheck, Inc. (Northridge, US). The FDA issued a Cleared decision on September 26, 2000 after a review of 180 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5630 - 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 Biocheck, Inc. devices

FDA 510(k) Submission Details - K001022

510(k) Number K001022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2000
Decision Date September 26, 2000
Days to Decision 180 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
75d slower than avg
Panel avg: 105d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JZG Device Classification - Class 2, Special Controls

Product Code JZG System, Test, Beta-2-microglobulin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5630
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 - JZG System, Test, Beta-2-microglobulin Immunological

All 46
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K001022.
QUANTIA BETA-2 MICROGLOBULIN
K050613 · Biokit, S.A. · Aug 2005
MININEPH HUMAN B2-MICROGLOBULIN KIT
K014270 · The Binding Site, Ltd. · Aug 2002
N LATEX B2-MICROGLOBULIN
K002731 · Dade Behring, Inc. · Nov 2000
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS)
K993711 · Bayer Corp. · Dec 1999
B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
K991136 · Olympus America, Inc. · May 1999
IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT
K983895 · Beckman Coulter, Inc. · Nov 1998