Cleared Traditional

PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE (K780858) - FDA 510(k) Clearance

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

K780858 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Jun 1978
Decision
29d
Days
Class 2
Risk

K780858 is an FDA 510(k) clearance for the PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE. 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 June 22, 1978 after a review of 29 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 K780858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1978
Decision Date June 22, 1978
Days to Decision 29 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
59d faster than avg
Panel avg: 88d · This submission: 29d
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 K780858.
GLUCOSE-HK SYSTEM PACK TEST
K812303 · Boehringer Mannheim Corp. · Sep 1981
HEXOKINASE, GLUCOSE
K802810 · Beckman Instruments, Inc. · Dec 1980
F/LS MCA APPLICATION SOFTWARE
K801456 · Instrumentation Laboratory CO · Oct 1980
MULTISTAT III GLUCOSE TEST
K771464 · Instrumentation Laboratory CO · Sep 1977
AUTOZYME IMMOBILIZED ENZYME COIL
K771384 · Technicon Instruments Corp. · Aug 1977
GLUCOSE (HEXOKINASE) DELTA TEST ASSAY
K770262 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1977