Cleared Traditional

K780393 - BIOSTATOR GLUCOSE ANALYZER

K780393 is an FDA 510(k) clearance for BIOSTATOR GLUCOSE ANALYZER, manufactured by Miles Laboratories, Inc.. The device is a Class 2 Hematology device with product code CGA cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K780393 · Miles Laboratories, Inc. · Hematology device
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Jun 1978
Decision
101d
Days
Class 2
Risk

K780393 is an FDA 510(k) clearance for the BIOSTATOR GLUCOSE ANALYZER. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on June 19, 1978 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1345 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Miles Laboratories, Inc. devices

FDA 510(k) Submission Details - K780393

510(k) Number K780393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1978
Decision Date June 19, 1978
Days to Decision 101 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 113d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, 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 Hematology devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 301
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K780393.
GLUCOSE OXIDASE REAGENT SET
K791669 · Macomb Chemical Co. · Sep 1979
GLUCOSE REAGENT
K791685 · Hi Chem, Inc. · Sep 1979
STATTEK-GLUCOSE LOW LEVEL
K781075 · Boehringer Mannheim Corp. · Aug 1978
AUTOZYME GLUCOSE OXIDASE (TRINDER)
K772308 · J.T. Baker Chemical Co. · Mar 1978
GLUCOSE REAGENT FOR GLUCOSE ANALYZER
K780093 · Harleco · Feb 1978
GLUCOSE REAGENT FOR GLUC. ANALYZER
K771754 · Harleco · Oct 1977