Cleared Traditional

IDEIA HERPES SIMPLEX VIRUS TEST (K871877) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K871877 · Boots-Celltech Diagnostics, Inc. · Microbiology device
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Nov 1989
Decision
918d
Days
Class 2
Risk

K871877 is an FDA 510(k) clearance for the IDEIA HERPES SIMPLEX VIRUS TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (product code LGC), Class II - Special Controls.

Submitted by Boots-Celltech Diagnostics, Inc. (Berkshire, England, GB). The FDA issued a Cleared decision on November 17, 1989 after a review of 918 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Boots-Celltech Diagnostics, Inc. devices

Submission Details

510(k) Number K871877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1987
Decision Date November 17, 1989
Days to Decision 918 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
816d slower than avg
Panel avg: 102d · This submission: 918d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
Devices cleared under the same product code (LGC) and FDA review panel - the closest regulatory comparables to K871877.
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K010878 · Diagnostic Products Corp. · Apr 2001
IMMULITE HERPES I AND II IGG
K950670 · Diagnostic Products Corp. · Jun 1996
KODAK SURECELL HERPES (HSV) CONTROL FLUID SET
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HERPTRAN CONCENTRATE
K900713 · E.I. Dupont DE Nemours & Co., Inc. · May 1990
KODAK SURECELL HERPES (HSV) TEST KIT
K884680 · Eastman Kodak Company · Feb 1989
ABBOTT HSV EIA
K843622 · Abbott Laboratories · May 1985