Cleared Traditional

K843725 - BIOGRAM

K843725 is the FDA 510(k) clearance for BIOGRAM by Giles Scientific, Inc.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K843725 · Giles Scientific, Inc. · Microbiology device
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May 1985
Decision
239d
Days
Class 2
Risk

K843725 is an FDA 510(k) clearance for the BIOGRAM. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Giles Scientific, Inc. (Walker, US). The FDA issued a Cleared decision on May 21, 1985 after a review of 239 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1620 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Giles Scientific, Inc. devices

Submission Details

510(k) Number K843725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1984
Decision Date May 21, 1985
Days to Decision 239 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 102d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JTN Susceptibility Test Discs, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1620
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 Microbiology devices follow this clearance model.

Regulatory Peers - JTN Susceptibility Test Discs, Antimicrobial

All 295
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K843725.
GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK
K852967 · Warner-Lambert Co. · Aug 1985
CEFTAZIDIME 30 MCG SENSITVITY DISCS
K852835 · Difco Laboratories, Inc. · Aug 1985
TIMENTIN 85 MCG. SENSI-DISC
K851622 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1985
GENERAL DIAGNOSTICS TICARCILLIN 75MCG SUSCEPT-DISK
K850957 · Warner-Lambert Co. · May 1985
GENERAL DIAGNOSTICS AUGMENTIN 30MCG SUSCEP DISK
K851228 · Warner-Lambert Co. · Apr 1985
CEFTRIAXONE 30 MCG SENSITIVITY DISCS
K850606 · Difco Laboratories, Inc. · Apr 1985