Cleared Traditional

K900167 - TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT

K900167 is an FDA 510(k) clearance for TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DCF cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K900167 · Behring Diagnostics, Inc. · Immunology device
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Jan 1990
Decision
10d
Days
Class 2
Risk

K900167 is an FDA 510(k) clearance for the TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT. Classified as Albumin, Antigen, Antiserum, Control (product code DCF), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on January 22, 1990 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5040 - 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 Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K900167

510(k) Number K900167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1990
Decision Date January 22, 1990
Days to Decision 10 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 105d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCF Device Classification - Class 2, Special Controls

Product Code DCF Albumin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5040
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 - DCF Albumin, Antigen, Antiserum, Control

All 34
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K900167.
IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
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COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
K961824 · Roche Diagnostic Systems, Inc. · Jul 1996
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K914391 · The Binding Site, Ltd. · Dec 1991
MODIFIED QM300 ALBUMIN ANTIBODY PACK
K896059 · Kallestad Diag, A Div. of Erbamont, Inc. · Nov 1989
TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN
K895808 · Technicon Instruments Corp. · Oct 1989
TECHNICON DPA-1(TM) SYSTEM
K882153 · Technicon Instruments Corp. · Aug 1988