Cleared Traditional

K971405 - SPECIALITY URINE 1

K971405 is an FDA 510(k) clearance for SPECIALITY URINE 1, manufactured by Chiron Diagnostics Corp.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K971405 · Chiron Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
61d
Days
Class 1
Risk

K971405 is an FDA 510(k) clearance for the SPECIALITY URINE 1,2. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Chiron Diagnostics Corp. (Irvine, US). The FDA issued a Cleared decision on June 16, 1997 after a review of 61 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 Chiron Diagnostics Corp. devices

FDA 510(k) Submission Details - K971405

510(k) Number K971405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1997
Decision Date June 16, 1997
Days to Decision 61 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
27d faster than avg
Panel avg: 88d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

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 546
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K971405.
NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS
K972070 · Nichols Institute Diagnostics · Jun 1997
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
K972214 · Roche Diagnostic Systems, Inc. · Jun 1997
QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3
K972080 · Consolidated Technologies, Inc. · Jun 1997
LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600)
K971952 · Bio-Rad · Jun 1997
LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)
K971954 · Bio-Rad · Jun 1997
LIQUID LIGAND 1,2,3
K971071 · Chiron Diagnostics Corp. · Apr 1997