Cleared Traditional

K063852 - ACCESSA CHOLESTEROL PANEL

K063852 is an FDA 510(k) clearance for ACCESSA CHOLESTEROL PANEL, manufactured by Home Access Health Corp.. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K063852 · Home Access Health Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
316d
Days
Class 2
Risk

K063852 is an FDA 510(k) clearance for the ACCESSA CHOLESTEROL PANEL. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Home Access Health Corp. (Hoffman Estates, US). The FDA issued a Cleared decision on November 9, 2007 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Home Access Health Corp. devices

FDA 510(k) Submission Details - K063852

510(k) Number K063852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2006
Decision Date November 09, 2007
Days to Decision 316 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
228d slower than avg
Panel avg: 88d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 Chemistry devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 165
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K063852.
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