Cleared Traditional

K961024 - BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB

K961024 is an FDA 510(k) clearance for BIOSIGN MONO-PLUS WB, manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 327-day FDA review.

K961024 · Princeton BioMeditech Corp. · Immunology device
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Feb 1997
Decision
327d
Days
Class 2
Risk

K961024 is an FDA 510(k) clearance for the BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on February 4, 1997 after a review of 327 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5640 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K961024

510(k) Number K961024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1996
Decision Date February 04, 1997
Days to Decision 327 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 105d · This submission: 327d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTN Device Classification - Class 2, Special Controls

Product Code KTN System, Test, Infectious Mononucleosis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5640
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 Immunology devices follow this clearance model.

Regulatory Peers - KTN System, Test, Infectious Mononucleosis

All 42
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K961024.
MONOCOL/LEX-IM TEST
K972457 · Immunostics Inc., · Dec 1997
OSOM MONO TEST 143
K972231 · Wyntek Diagnostics, Inc. · Aug 1997
GENZYME DIAGNOSTICS CONTRAST MONO
K963425 · Genzyme Diagnostics · Feb 1997
QUALITROL MONO CONTROL SERUM SET
K961550 · Consolidated Technologies, Inc. · Sep 1996
IMMUNOCARD MONO
K930778 · Meridian Diagnostics, Inc. · Dec 1993
EYE SPOT IM TEST
K932688 · J.S. Medical Assoc. · Sep 1993