Cleared Traditional

K981651 - AB FLU OIA

K981651 is an FDA 510(k) clearance for AB FLU OIA, manufactured by Biostar, Inc.. The device is a Class 2 Microbiology device with product code PSZ cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K981651 · Biostar, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
198d
Days
Class 2
Risk

K981651 is an FDA 510(k) clearance for the AB FLU OIA. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by Biostar, Inc. (Boulder, US). The FDA issued a Cleared decision on November 25, 1998 after a review of 198 days - an extended review 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: 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 Biostar, Inc. devices

FDA 510(k) Submission Details - K981651

510(k) Number K981651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1998
Decision Date November 25, 1998
Days to Decision 198 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 102d · This submission: 198d
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.

Regulatory Peers - PSZ Devices Detecting Influenza A, B, And C Virus Antigens

All 62
Devices cleared under the same product code (PSZ) and FDA review panel - the closest regulatory comparables to K981651.
BD DIRECTIGEN FLU A+B
K001364 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 2000
ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST
K993048 · Roche Diagnostics Corp. · Dec 1999
QUICKVUE INFLUENZA A/B TEST
K991633 · Quidel Corp. · Sep 1999
ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES
K982429 · Zymetx, Inc. · Aug 1998