Cleared Traditional

K895582 - QCLYTE PROTEIN-BASED ISE CONTROL

K895582 is the FDA 510(k) clearance for QCLYTE PROTEIN-BASED ISE CONTROL by Baxter Healthcare Corp. It is a Class 1 Chemistry device (product code JJR) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K895582 · Baxter Healthcare Corp · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
19d
Days
Class 1
Risk

K895582 is an FDA 510(k) clearance for the QCLYTE PROTEIN-BASED ISE CONTROL. Classified as Electrolyte Controls (assayed And Unassayed) (product code JJR), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on October 4, 1989 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K895582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1989
Decision Date October 04, 1989
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJR Electrolyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJR Electrolyte Controls (assayed And Unassayed)

All 9
Devices cleared under the same product code (JJR) and FDA review panel - the closest regulatory comparables to K895582.
AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL
K951435 · Aalto Scientific, Ltd. · May 1995
SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING
K943925 · Quantimetrix Corp. · Oct 1994
CIBA CORNING CERTAIN LYTE
K894576 · Ciba Corning Diagnostics Corp. · Oct 1989
DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET
K881773 · Casco Standards · Jun 1988
PROTEIN BASE ISE CONTROL
K880710 · Bionostics, Inc. · Mar 1988
AVL ISE-TROL ELECTROLYTE CONTROL
K863333 · Avl Scientific Corp. · Sep 1986