Cleared Traditional

ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH (K973678) - FDA 510(k) Clearance

Class I Chemistry device.

K973678 · Sorrento Biochemical, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
80d
Days
Class 1
Risk

K973678 is an FDA 510(k) clearance for the ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + 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

Submission Details

510(k) Number K973678 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
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 88d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 492
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K973678.
Beta-CrossLaps CalCheck 5
K170678 · Roche Diagnostics · Apr 2017
Elecsys CYFRA 21-1 CalCheck 5
K162173 · Roche Diagnostics · Jan 2017
Elecsys Progesterone III Cal Check 5
K150955 · Roche Diagnostics · May 2015
Elecsys Estradiol III Calcheck
K143284 · Roche Diagnostics · Dec 2014
ELECSYS ESTRADIOL III CALCHECK 5
K142127 · Roche Diagnostics · Sep 2014
ELECSYS PRECICONTROL TS
K140534 · Roche Diagnostics · Mar 2014