Cleared Traditional

K844399 - RESPIRALEX LATEX AGGLUTINATION TEST

K844399 is an FDA 510(k) clearance for RESPIRALEX LATEX AGGLUTINATION TEST, manufactured by Orion Diagnostica, Inc.. The device is a Class 1 Immunology device with product code GTZ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K844399 · Orion Diagnostica, Inc. · Immunology device
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Jan 1985
Decision
56d
Days
Class 1
Risk

K844399 is an FDA 510(k) clearance for the RESPIRALEX LATEX AGGLUTINATION TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Orion Diagnostica, Inc. (Somerset, US). The FDA issued a Cleared decision on January 8, 1985 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3740 - the FDA immunology 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 Orion Diagnostica, Inc. devices

FDA 510(k) Submission Details - K844399

510(k) Number K844399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1984
Decision Date January 08, 1985
Days to Decision 56 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 105d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

GTZ Device Classification - Class 1, General Controls

Product Code GTZ Antisera, All Groups, Streptococcus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
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 - GTZ Antisera, All Groups, Streptococcus Spp.

All 89
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