Cleared Traditional

K880313 - WAKO(TM) AUTOKIT ALBUMIN

K880313 is the FDA 510(k) clearance for WAKO(TM) AUTOKIT ALBUMIN by Wako Chemicals USA, Inc.. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K880313 · Wako Chemicals USA, Inc. · Chemistry device
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Mar 1988
Decision
59d
Days
Class 2
Risk

K880313 is an FDA 510(k) clearance for the WAKO(TM) AUTOKIT ALBUMIN. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on March 24, 1988 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - the FDA in vitro diagnostics and chemistry 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 Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K880313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1988
Decision Date March 24, 1988
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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 Chemistry devices follow this clearance model.

Regulatory Peers - CIX Bromcresol Green Dye-binding, Albumin

All 76
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K880313.
BIOTROL ALBUMIN
K885094 · Biotrol, USA, Inc. · Feb 1989
ALBUMIN TEST (ALB) ITEM #65650
K884705 · Em Diagnostic Systems, Inc. · Jan 1989
ALBUMIN CAT. # 201-03
K875207 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1988
ALBUMIN, BROMCRESOL GREEN DYE-BINDING
K875070 · Tech-Co, Inc. · Jan 1988
ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS
K874163 · Catachem, Inc. · Nov 1987
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
K873994 · Em Diagnostic Systems, Inc. · Oct 1987