Cleared Traditional

K822471 - PSI ALBUMIN REAGENT

K822471 is the FDA 510(k) clearance for PSI ALBUMIN REAGENT by Pointe Scientific, Inc.,. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K822471 · Pointe Scientific, Inc., · Chemistry device
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Sep 1982
Decision
28d
Days
Class 2
Risk

K822471 is an FDA 510(k) clearance for the PSI ALBUMIN REAGENT. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982 after a review of 28 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K822471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1982
Decision Date September 14, 1982
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 K822471.
FLOW-PAC ALBUMIN REAGENT
K830536 · Amresco, Inc. · Mar 1983
COBAS REAGENT FOR ALBUMIN
K823574 · Hoffmann-La Roche, Inc. · Jan 1983
COBAS STANDARDS FOR ALBUMIN
K823575 · Hoffmann-La Roche, Inc. · Jan 1983
ALBUMIN REAGENT
K821225 · Hi Chem, Inc. · May 1982
ULTRACHEM ALB, ITEM #64970
K813044 · Harleco · Nov 1981
KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB)
K812030 · Eastman Kodak Company · Aug 1981