Cleared Traditional

K933435 - DADE URINE CHEMISTRY CONTROL

K933435 is the FDA 510(k) clearance for DADE URINE CHEMISTRY CONTROL by Baxter Diagnostics, Inc.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K933435 · Baxter Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Sep 1993
Decision
72d
Days
Class 1
Risk

K933435 is an FDA 510(k) clearance for the DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on September 24, 1993 after a review of 72 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 Diagnostics, Inc. devices

Submission Details

510(k) Number K933435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1993
Decision Date September 24, 1993
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 88d · This submission: 72d
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 463
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K933435.
DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3
K933437 · Baxter Diagnostics, Inc. · Oct 1993
LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2
K934357 · Bio-Rad · Oct 1993
TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3
K934056 · Medical Analysis Systems, Inc. · Oct 1993
BECKMAN VIGIL PLUS CONTROL
K930850 · Beckman Instruments, Inc. · Sep 1993
LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2
K933317 · Bio-Rad · Aug 1993
DADE(R) TUMOR MARKER CONTROL
K924919 · Baxter Diagnostics, Inc. · Aug 1993