Cleared Traditional

A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM (K882587) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K882587 · A-Kem, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
46d
Days
Class 2
Risk

K882587 is an FDA 510(k) clearance for the A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by A-Kem, Inc. (Clifton, US). The FDA issued a Cleared decision on August 8, 1988 after a review of 46 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 A-Kem, Inc. devices

Submission Details

510(k) Number K882587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1988
Decision Date August 08, 1988
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
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 25
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K882587.
ALBUMIN TEST (ALB) ITEM NUMBER: 65401
K893777 · Em Diagnostic Systems, Inc. · Aug 1989
IQ ALBUMIN
K891375 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1989
ALBUMIN TEST (ALB) ITEM #65650
K884705 · Em Diagnostic Systems, Inc. · Jan 1989
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
K873994 · Em Diagnostic Systems, Inc. · Oct 1987
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
K864715 · Em Diagnostic Systems, Inc. · Dec 1986
TDX AMYLASE
K853978 · Abbott Laboratories · Oct 1985