Cleared Traditional

K921628 - EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA

K921628 is an FDA 510(k) clearance for EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CL..., manufactured by Incstar Corp.. The device is a Class 1 Microbiology device with product code LSE cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K921628 · Incstar Corp. · Microbiology device
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Sep 1992
Decision
161d
Days
Class 1
Risk

K921628 is an FDA 510(k) clearance for the EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on September 14, 1992 after a review of 161 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3235 - 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 Incstar Corp. devices

FDA 510(k) Submission Details - K921628

510(k) Number K921628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1992
Decision Date September 14, 1992
Days to Decision 161 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
59d slower than avg
Panel avg: 102d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

LSE Device Classification - Class 1, General Controls

Product Code LSE Epstein-barr Virus, Other
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3235
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 - LSE Epstein-barr Virus, Other

All 47
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K921628.
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT
K946157 · Incstar Corp. · Jun 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT
K946159 · Incstar Corp. · Jun 1995
ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
K931443 · Ortho Diagnostic Systems, Inc. · Nov 1993
BARTELS EPSTEIN-BARR VIRUS IGG EIA
K922332 · Baxter Diagnostics, Inc. · Sep 1992
FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS
K912488 · Immuno Concepts, Inc. · Jul 1991
COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS
K912489 · Immuno Concepts, Inc. · Jul 1991