Cleared Traditional

K063852 - ACCESSA CHOLESTEROL PANEL

K063852 is the FDA 510(k) clearance for ACCESSA CHOLESTEROL PANEL by Home Access Health Corp.. It is a Class 2 Chemistry device (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

Submission Details

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.

Device Classification

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 116
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K063852.
HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI
K090737 · Bio-Rad Laboratories, Inc. · Jun 2009
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING
K081229 · Smiths Medical Asd, Inc. · Jul 2008
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH
K072783 · Smiths Medical Asd, Inc. · Nov 2007
VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE
K060364 · Teco Diagnostics · Jun 2006
CYTO-CHEX BCT
K040107 · Streck Laboratories, Inc. · Jul 2004
BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381
K041071 · Becton, Dickinson & CO · May 2004