Cleared Traditional

K823805 - VARICELISA TEST KIT

K823805 is an FDA 510(k) clearance for VARICELISA TEST KIT, manufactured by M.A. Bioproducts. The device is a Class 2 Microbiology device with product code LFY cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K823805 · M.A. Bioproducts · Microbiology device
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May 1983
Decision
139d
Days
Class 2
Risk

K823805 is an FDA 510(k) clearance for the VARICELISA TEST KIT. Classified as Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (product code LFY), Class II - Special Controls.

Submitted by M.A. Bioproducts (Mchenry, US). The FDA issued a Cleared decision on May 5, 1983 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3900 - 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 M.A. Bioproducts devices

FDA 510(k) Submission Details - K823805

510(k) Number K823805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1982
Decision Date May 05, 1983
Days to Decision 139 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 102d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFY Device Classification - Class 2, Special Controls

Product Code LFY Enzyme Linked Immunoabsorbent Assay, Varicella-zoster
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3900
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.