Cleared Traditional

K972214 - ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)

K972214 is an FDA 510(k) clearance for ROCHE SERUM CONTROL NORMAL (HUMAN), manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K972214 · Roche Diagnostic Systems, Inc. · Chemistry device
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Jun 1997
Decision
12d
Days
Class 1
Risk

K972214 is an FDA 510(k) clearance for the ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN). Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on June 24, 1997 after a review of 12 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 Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K972214

510(k) Number K972214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1997
Decision Date June 24, 1997
Days to Decision 12 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 88d · This submission: 12d
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 591
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