Cleared Traditional

K946048 - LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2

K946048 is an FDA 510(k) clearance for LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL ..., manufactured by Clinical Controls, Inc.. The device is a Class 2 Immunology device with product code JZG cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K946048 · Clinical Controls, Inc. · Immunology device
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Feb 1995
Decision
60d
Days
Class 2
Risk

K946048 is an FDA 510(k) clearance for the LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Clinical Controls, Inc. (Grover Beach, US). The FDA issued a Cleared decision on February 10, 1995 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Clinical Controls, Inc. devices

FDA 510(k) Submission Details - K946048

510(k) Number K946048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1994
Decision Date February 10, 1995
Days to Decision 60 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 105d · This submission: 60d
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 45
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K946048.
HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT
K946070 · The Binding Site, Ltd. · Jan 1996
AURAFLEX B2-MICROGLOBULIN
K944846 · Organon Teknika Corp. · Jun 1995
IL TEST BETA-2MICROGLOBULIN
K943686 · Instrumentation Laboratory CO · May 1995
BECKMAN BETA-2-MICROGLOBULIN (B2M)
K940353 · Beckman Instruments, Inc. · Apr 1994
IMMULITE BETA-2-MICROGLOBULIN
K931702 · Diagnostic Products Corp. · Sep 1993
ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK
K933648 · Dupont Medical Products · Sep 1993