Cleared Traditional

K843725 - BIOGRAM

K843725 is an FDA 510(k) clearance for BIOGRAM, manufactured by Giles Scientific, Inc.. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K843725

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.

JTN Device Classification - Class 2, Special Controls

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 324
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