Cleared Traditional

GLUCOSE (HEXOKINASE) DELTA TEST ASSAY (K770262) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K770262 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Feb 1977
Decision
12d
Days
Class 2
Risk

K770262 is an FDA 510(k) clearance for the GLUCOSE (HEXOKINASE) DELTA TEST ASSAY. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on February 23, 1977 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K770262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1977
Decision Date February 23, 1977
Days to Decision 12 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 88d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFR Hexokinase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CFR Hexokinase, Glucose

All 51
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K770262.
PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE
K780858 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1978
MULTISTAT III GLUCOSE TEST
K771464 · Instrumentation Laboratory CO · Sep 1977
AUTOZYME IMMOBILIZED ENZYME COIL
K771384 · Technicon Instruments Corp. · Aug 1977
GLUCOSE REAGENT SYS, SIGMA PROCED. 115
K760247 · Sigma Chemical Co. · Aug 1976