Cleared Traditional

K141944 - HOME ACCESS AIC TEST

K141944 is an FDA 510(k) clearance for HOME ACCESS AIC TEST, manufactured by Home Access Health Corp.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K141944 · Home Access Health Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
239d
Days
Class 2
Risk

K141944 is an FDA 510(k) clearance for the HOME ACCESS AIC TEST. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Home Access Health Corp. (Marlborough, US). The FDA issued a Cleared decision on March 13, 2015 after a review of 239 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - 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. Standard predicate reliance. 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 - K141944

510(k) Number K141944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2014
Decision Date March 13, 2015
Days to Decision 239 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 88d · This submission: 239d
Pathway characteristics
Predicate-based equivalence.

LCP Device Classification - Class 2, Special Controls

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Regulatory Consultant

Icon Clinical Research, LLC
Sandra D White

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT01913145 Completed Interventional Industry-sponsored

Comparison Study of Lay Person Finger Stick Versus Blood Draw

Usability and HbA1c Method Comparison Study Using Lay Person Micro-Blood Specimens

128
Patients (actual)
2
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Diabetes
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator David Klonoff, MD
Sponsor Home Access Health Corporation (industry)
Started 2012-05-01 → Primary completion 2012-10-01
Primary outcome
Usability and HbA1c Method Comparison Study Using Lay-Person Micro-Blood Specimens
Study completed - no results published. This trial concluded in 2012 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 202
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