Cleared Traditional

K854521 - BIOGRAM

K854521 is an FDA 510(k) clearance for BIOGRAM, manufactured by Giles Scientific, Inc.. The device is a Class 2 Microbiology device with product code JTZ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K854521 · Giles Scientific, Inc. · Microbiology device
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Dec 1985
Decision
41d
Days
Class 2
Risk

K854521 is an FDA 510(k) clearance for the BIOGRAM. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Giles Scientific, Inc. (New York, US). The FDA issued a Cleared decision on December 23, 1985 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - 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: 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 Giles Scientific, Inc. devices

FDA 510(k) Submission Details - K854521

510(k) Number K854521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1985
Decision Date December 23, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 102d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTZ Device Classification - Class 2, Special Controls

Product Code JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
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 - JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth

All 45
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K854521.
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K864247 · Mds Laboratories, Inc. · Mar 1987
MUELLER HINTON AGAR - SUPPLEMENTED
K864248 · Mds Laboratories, Inc. · Mar 1987
MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
K863821 · Gibco Laboratories Life Technologies, Inc. · Oct 1986
APL MUELLER HINTON AGAR
K853238 · Apl Medical Supplies · Aug 1985
MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
K850291 · Remel Co. · May 1985
MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE
K851589 · Preferred Micro-Media · Apr 1985