Cleared Traditional

K895808 - TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN

K895808 is the FDA 510(k) clearance for TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN by Technicon Instruments Corp.. It is a Class 2 Immunology device (product code DCF) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K895808 · Technicon Instruments Corp. · Immunology device
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Oct 1989
Decision
15d
Days
Class 2
Risk

K895808 is an FDA 510(k) clearance for the TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN. Classified as Albumin, Antigen, Antiserum, Control (product code DCF), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on October 17, 1989 after a review of 15 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K895808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1989
Decision Date October 17, 1989
Days to Decision 15 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
89d faster than avg
Panel avg: 104d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K895808.
ALBUMIN TEST RID KIT
K914391 · The Binding Site, Ltd. · Dec 1991
TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT
K900167 · Behring Diagnostics, Inc. · Jan 1990
MODIFIED QM300 ALBUMIN ANTIBODY PACK
K896059 · Kallestad Diag, A Div. of Erbamont, Inc. · Nov 1989
TECHNICON DPA-1(TM) SYSTEM
K882153 · Technicon Instruments Corp. · Aug 1988
QM300 ALBUMIN ANTIBODY PACK
K882082 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1988
QM300 CALIBRATOR D PACK
K881127 · Kallestad Diag, A Div. of Erbamont, Inc. · Apr 1988