Cleared Traditional

K952595 - HAEMOPHILUS TEST MEDIUM (HTM)

K952595 is an FDA 510(k) clearance for HAEMOPHILUS TEST MEDIUM (HTM), manufactured by Clinical Standards Laboratories, Inc.. The device is a Class 2 Microbiology device with product code JSO cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K952595 · Clinical Standards Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
309d
Days
Class 2
Risk

K952595 is an FDA 510(k) clearance for the HAEMOPHILUS TEST MEDIUM (HTM). Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Clinical Standards Laboratories, Inc. (Rancho Dominguez, US). The FDA issued a Cleared decision on April 10, 1996 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Clinical Standards Laboratories, Inc. devices

FDA 510(k) Submission Details - K952595

510(k) Number K952595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1995
Decision Date April 10, 1996
Days to Decision 309 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 102d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JSO Device Classification - Class 2, Special Controls

Product Code JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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 - JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

All 33
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K952595.
MRSASELECT
K070361 · Bio-Rad · Sep 2007
BBLCHROMAGAR MRSA
K042812 · Becton, Dickinson & CO · Nov 2004
BHI W/VANCOMYCIN AGAR
K964560 · Hardy Diagnostics · Jan 1997
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
K951754 · Hardy Diagnostics · Oct 1995
GCII AGAR WITH ISOVITALX(R) ENRICHMENT
K945569 · Becton Dickinson Microbiology Systems · Feb 1995
BRAIN HEART INFUSION AGAR
K944554 · Carr-Scarborough Microbiologicals, Inc. · Oct 1994