Cleared Traditional

K864668 - ANA TEST KIT

K864668 is an FDA 510(k) clearance for ANA TEST KIT, manufactured by Val Tech Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LKJ cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K864668 · Val Tech Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
100d
Days
Class 2
Risk

K864668 is an FDA 510(k) clearance for the ANA TEST KIT. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Val Tech Diagnostics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on March 12, 1987 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 Val Tech Diagnostics, Inc. devices

FDA 510(k) Submission Details - K864668

510(k) Number K864668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1986
Decision Date March 12, 1987
Days to Decision 100 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 105d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKJ Device Classification - Class 2, Special Controls

Product Code LKJ Antinuclear Antibody, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - LKJ Antinuclear Antibody, Antigen, Control

All 38
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K864668.
ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
K883883 · Immco Diagnostics, Inc. · Oct 1988
ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)
K883949 · Immco Diagnostics, Inc. · Oct 1988
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
K874115 · Sigma Diagnostics, Inc. · Nov 1987
KALLESTAD SM/RNP TEST REAGENT
K862313 · Kallestad Laboratories, Inc. · Aug 1986
SERATEST DNA DETERMINATION
K842563 · Seragen Diagnostics, Inc. · Oct 1984
LEAP LE TEST KIT
K842484 · Cooper Biomedical, Inc. · Jul 1984