Cleared Traditional

DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL (K880175) - FDA 510(k) Clearance

Class I Chemistry device.

K880175 · Baxter Healthcare Corp · Chemistry device
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Mar 1988
Decision
46d
Days
Class 1
Risk

K880175 is an FDA 510(k) clearance for the DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on March 1, 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 862.1660 - 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 K880175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1988
Decision Date March 01, 1988
Days to Decision 46 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
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 165
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K880175.
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL
K881503 · Baxter Healthcare Corp · Jul 1988
AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693
K881229 · Em Diagnostic Systems, Inc. · May 1988
LYPHOCHEK SPINAL FLUID CONTROL (HUMAN)
K880494 · Bio-Rad · Mar 1988
LYPHOCHEK WHOLE BLOOD CONTROL
K874731 · Bio-Rad · Feb 1988
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II
K874280 · Bio-Rad · Jan 1988
PRECINORM L
K874230 · Boehringer Mannheim Corp. · Nov 1987