Cleared Traditional

K964053 - HEMOCUE GLUCOTROL

K964053 is an FDA 510(k) clearance for HEMOCUE GLUCOTROL, manufactured by Direct Solutions. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K964053 · Direct Solutions · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
32d
Days
Class 1
Risk

K964053 is an FDA 510(k) clearance for the HEMOCUE GLUCOTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Direct Solutions (Westford, US). The FDA issued a Cleared decision on November 1, 1996 after a review of 32 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 Direct Solutions devices

FDA 510(k) Submission Details - K964053

510(k) Number K964053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1996
Decision Date November 01, 1996
Days to Decision 32 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
56d faster than avg
Panel avg: 88d · This submission: 32d
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 445
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K964053.
ELECSYS CALCHECK LH
K964830 · Boehringer Mannheim Corp. · Dec 1996
WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6
K964278 · Clinical Controls, Inc. · Nov 1996
HEMOCUE GLUCOLIN
K963909 · Direct Solutions · Nov 1996
RADIAS GALT TEST
K961432 · Bio-Rad · Oct 1996
BIO-CSF LIQUID CONTROL LEVEL 1 AND 2
K963551 · Biocell Laboratories, Inc. · Oct 1996
ELECSYS CALCHECK T UPDATE
K963181 · Boehringer Mannheim Corp. · Sep 1996