Cleared Traditional

K970956 - CERTAIN COMPLETE LEVELS 1

Also marketed or referenced as:
CVM LEVELS 1,2,3,4, AND 5

K970956 is an FDA 510(k) clearance for CERTAIN COMPLETE LEVELS 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 22-day FDA review.

K970956 · Chiron Diagnostics Corp. · Chemistry device
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Apr 1997
Decision
22d
Days
Class 1
Risk

K970956 is an FDA 510(k) clearance for the CERTAIN COMPLETE LEVELS 1,2, AND 3. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on April 8, 1997 after a review of 22 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 - K970956

510(k) Number K970956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1997
Decision Date April 08, 1997
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
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 K970956.
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SPINALSCOPICS
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CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
K970976 · Medical Analysis Systems, Inc. · Apr 1997
LIQUID CSF(LCR)1, LIQUID CSF(LCR)2
K970979 · Chiron Diagnostics Corp. · Apr 1997
TUMOR MARKER CONTROL
K965114 · Diagnostic Products Corp. · Feb 1997