Cleared Traditional

K973677 - DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH

K973677 is an FDA 510(k) clearance for DIASCAN AQUEOUS GLUCOSE CONTROL LOW, manufactured by Sorrento Biochemical, Inc.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K973677 · Sorrento Biochemical, Inc. · Chemistry device
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Dec 1997
Decision
80d
Days
Class 1
Risk

K973677 is an FDA 510(k) clearance for the DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Sorrento Biochemical, Inc. (San Diego, US). The FDA issued a Cleared decision on December 15, 1997 after a review of 80 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 Sorrento Biochemical, Inc. devices

FDA 510(k) Submission Details - K973677

510(k) Number K973677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1997
Decision Date December 15, 1997
Days to Decision 80 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
8d faster than avg
Panel avg: 88d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 421
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K973677.
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