Cleared Traditional

K000238 - HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G

K000238 is an FDA 510(k) clearance for HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLO..., manufactured by Mrl Diagnostics. The device is a Class 2 Microbiology device with product code LGC cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K000238 · Mrl Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
78d
Days
Class 2
Risk

K000238 is an FDA 510(k) clearance for the HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G. Classified as Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (product code LGC), Class II - Special Controls.

Submitted by Mrl Diagnostics (Cypress, US). The FDA issued a Cleared decision on April 14, 2000 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3305 - 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.

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FDA 510(k) Submission Details - K000238

510(k) Number K000238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2000
Decision Date April 14, 2000
Days to Decision 78 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
24d faster than avg
Panel avg: 102d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGC Device Classification - Class 2, Special Controls

Product Code LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
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 - LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific

All 33
Devices cleared under the same product code (LGC) and FDA review panel - the closest regulatory comparables to K000238.
MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
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THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
K992166 · Zeus Scientific, Inc. · Sep 1999
POCKIT HSV 2 RAPID TEST
K983886 · Diagnology , Ltd. · Aug 1999
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K984346 · Meridian Diagnostics, Inc. · Jun 1999
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K983656 · Zeus Scientific, Inc. · Mar 1999