Cleared Traditional

ANTIGENZ CHLAMYDIA (K905402) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K905402 · Northumbria Biologicals , Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
98d
Days
Class 2
Risk

K905402 is an FDA 510(k) clearance for the ANTIGENZ CHLAMYDIA. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Northumbria Biologicals , Ltd. (Cramlington, GB). The FDA issued a Cleared decision on March 11, 1991 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 882.5880 - 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 Northumbria Biologicals , Ltd. devices

Submission Details

510(k) Number K905402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1990
Decision Date March 11, 1991
Days to Decision 98 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 102d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
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 - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 138
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K905402.
Nalu Neurostimulation System for Spinal Cord Stimulation
K233801 · Boston Scientific Neuromodulation · Aug 2024
Nalu Neurostimulation System
K221376 · Boston Scientific Neuromodulation · Jun 2022
Nalu Neurostimulation System
K203547 · Boston Scientific Neuromodulation · Mar 2021
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
K202274 · Boston Scientific Neuromodulation · Nov 2020
Nalu Neurostimulation SCS system
K201618 · Boston Scientific Neuromodulation · Jul 2020
SandShark Injectable Anchor (SIA) System
K191466 · Stimwave Technologies, Inc. · Nov 2019