Cleared Traditional

K982429 - ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES

K982429 is an FDA 510(k) clearance for ZSTATFLU TEST FOR INFLUENZA TYPES A AND..., manufactured by Zymetx, Inc.. The device is a Class 2 Microbiology device with product code PSZ cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K982429 · Zymetx, Inc. · Microbiology device
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Aug 1998
Decision
43d
Days
Class 2
Risk

K982429 is an FDA 510(k) clearance for the ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by Zymetx, Inc. (Oklahoma City, US). The FDA issued a Cleared decision on August 25, 1998 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3328 - 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 Zymetx, Inc. devices

FDA 510(k) Submission Details - K982429

510(k) Number K982429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1998
Decision Date August 25, 1998
Days to Decision 43 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 102d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PSZ Device Classification - Class 2, Special Controls

Product Code PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3328
Definition An Influenza Virus Antigen Detection Test System Is A Device Intended For The Qualitative Detection Of Influenza Viral Antigens Directly From Clinical Specimens In Patients With Signs And Symptoms Of Respiratory Infection.
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.