Cleared Traditional

K843622 - ABBOTT HSV EIA

K843622 is an FDA 510(k) clearance for ABBOTT HSV EIA, manufactured by Abbott Laboratories. The device is a Class 2 Immunology device with product code LGC cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K843622 · Abbott Laboratories · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
248d
Days
Class 2
Risk

K843622 is an FDA 510(k) clearance for the ABBOTT HSV EIA. Classified as Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (product code LGC), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 20, 1985 after a review of 248 days - an extended review cycle.

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

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K843622

510(k) Number K843622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1984
Decision Date May 20, 1985
Days to Decision 248 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
144d slower than avg
Panel avg: 104d · This submission: 248d
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 Immunology devices follow this clearance model.

Regulatory Peers - LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific

All 28
Devices cleared under the same product code (LGC) and FDA review panel - the closest regulatory comparables to K843622.
KODAK SURECELL HERPES (HSV) CONTROL FLUID SET
K903926 · Eastman Kodak Company · Sep 1990
HERPTRAN CONCENTRATE
K900713 · E.I. Dupont DE Nemours & Co., Inc. · May 1990
KODAK SURECELL HERPES (HSV) TEST KIT
K884680 · Eastman Kodak Company · Feb 1989
HSV ANTIGEN ELISA KIT
K834449 · Ortho Diagnostic Systems, Inc. · May 1984