Cleared Traditional

K890675 - THE TURBOX ANALYSER SYSTEM COMPLEMENT C...

K890675 is the FDA 510(k) clearance for THE TURBOX ANALYSER SYSTEM COMPLEMENT C... by Unipath , Ltd.. It is a Class 2 Immunology device (product code CZW) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K890675 · Unipath , Ltd. · Immunology device
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Mar 1989
Decision
25d
Days
Class 2
Risk

K890675 is an FDA 510(k) clearance for the THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4. Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by Unipath , Ltd. (Bedford Mk41 Oqg, GB). The FDA issued a Cleared decision on March 6, 1989 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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 Unipath , Ltd. devices

Submission Details

510(k) Number K890675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1989
Decision Date March 06, 1989
Days to Decision 25 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
79d faster than avg
Panel avg: 104d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZW Complement C3, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - CZW Complement C3, Antigen, Antiserum, Control

All 32
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K890675.
C3C AND C4 RID KITS
K902382 · The Binding Site, Ltd. · Sep 1990
EZ COMPLEMENT C2
K892125 · Diamedix Corp. · Apr 1989
EZ COMPLEMENT C3
K892127 · Diamedix Corp. · Apr 1989
QM300 C3 ANTIBODY PACK
K871939 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1987
PRECIMAT(R) C3
K871024 · Boehringer Mannheim Corp. · May 1987
DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY
K871346 · Dako Corp. · Apr 1987