Cleared Traditional

PSI TOTAL PROTEIN REAGENT (K822468) - FDA 510(k) Clearance

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

K822468 · Pointe Scientific, Inc., · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1982
Decision
28d
Days
Class 2
Risk

K822468 is an FDA 510(k) clearance for the PSI TOTAL PROTEIN REAGENT. Classified as Biuret (colorimetric), Total Protein (product code CEK), 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 862.1635 - 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 K822468 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
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 CEK Biuret (colorimetric), Total Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1635
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 - CEK Biuret (colorimetric), Total Protein

All 115
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K822468.
URINARY/CEREBROSPINAL FLUID PROTEIN
K934841 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1994
TOTAL PROTEIN TEST (TPRO)
K935174 · Em Diagnostic Systems, Inc. · Dec 1993
SYNCHRON TOTAL PROTEIN TEST --MODIFIED
K922467 · Beckman Instruments, Inc. · Nov 1992
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
K923267 · Em Diagnostic Systems, Inc. · Sep 1992
BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST
K914885 · Beckman Instruments, Inc. · Jan 1992
TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE
K913978 · Beckman Instruments, Inc. · Oct 1991