Cleared Traditional

K873297 - DIFFERENTIAL I.M. SCREENING TEST

K873297 is an FDA 510(k) clearance for DIFFERENTIAL I.M. SCREENING TEST, manufactured by Sclavo, Inc.. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K873297 · Sclavo, Inc. · Immunology device
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Dec 1987
Decision
118d
Days
Class 2
Risk

K873297 is an FDA 510(k) clearance for the DIFFERENTIAL I.M. SCREENING TEST. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on December 14, 1987 after a review of 118 days - within the typical 510(k) review window.

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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K873297

510(k) Number K873297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1987
Decision Date December 14, 1987
Days to Decision 118 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
13d slower than avg
Panel avg: 105d · This submission: 118d
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 58
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K873297.
MONO-PHILE
K881247 · Bio Diagnostic Systems, Inc. · Apr 1988
V-TREND IM DRY-SPOT TEST
K880399 · Texas Immunology, Inc. · Feb 1988
INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST
K880148 · Ampcor, Inc. · Feb 1988
I.M.N. LATEX
K874678 · Biokit USA, Inc. · Dec 1987
VENTRESCREEN (TM) MONO
K872032 · Ventrex Laboratories, Inc. · Jun 1987
DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO
K864207 · Gamma Biologicals, Inc. · Dec 1986
K873297 · DIFFERENTIAL I.M. SCREENING TEST
Download PDF Sclavo, Inc.