Cleared Traditional

K834338 - MYCOPLASMA PNEUMONIAE CF ANTIGEN

K834338 is an FDA 510(k) clearance for MYCOPLASMA PNEUMONIAE CF ANTIGEN, manufactured by Hillcrest Biologicals. The device is a Class 1 Microbiology device with product code GSB cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K834338 · Hillcrest Biologicals · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
77d
Days
Class 1
Risk

K834338 is an FDA 510(k) clearance for the MYCOPLASMA PNEUMONIAE CF ANTIGEN. Classified as Antigens, Cf, All, Mycoplasma Spp. (product code GSB), Class I - General Controls.

Submitted by Hillcrest Biologicals (Walker, US). The FDA issued a Cleared decision on February 27, 1984 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3375 - 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.

FDA 510(k) Submission Details - K834338

510(k) Number K834338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1983
Decision Date February 27, 1984
Days to Decision 77 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 102d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

GSB Device Classification - Class 1, General Controls

Product Code GSB Antigens, Cf, All, Mycoplasma Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3375
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GSB Antigens, Cf, All, Mycoplasma Spp.

Devices cleared under the same product code (GSB) and FDA review panel - the closest regulatory comparables to K834338.
MYCOPLASMA SPP SEROLOGICAL REAGENTS
K852933 · Microbix Biosystems, Inc. · Aug 1985
MYCOPLASMA PNEUMONIAE
K843664 · Institute Virion , Ltd. · Oct 1984
SERA-TEK MYCOPLASMA ANTIBODY TEST
K832132 · Miles Laboratories, Inc. · Sep 1983
MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL
K802934 · Orion Diagnostica, Inc. · Dec 1980
K834338 · MYCOPLASMA PNEUMONIAE CF ANTIGEN
Download PDF Hillcrest Biologicals