The Home Access® A1C Test is an in vitro test method for the quantitative measurement of Hemoglobin A1c using capillary blood collected from the fingertip, collected onto filter paper via the Home Access collection cassette. The Home Access AIC Test is for measurement of HbA1c on blood specimens which can be collected at the patient's home or in a healthcare professional setting and delivered to the laboratory by mail. Measurements obtained through this method can be used for monitoring the long-term control of blood sugar (glucose) in people with diabetes.

This test is not to be used to diagnose or screen for diabetes. Not for use on neonates.

Device Description

The Home Access® A1C Test includes a micro-blood specimen collection kit. The collection kit is intended to facilitate in vitro laboratory testing of finger stick blood samples for a variety of clinical chemistry assays.

This collection kit includes components needed to self-collect, package and mail a dried micro-blood sample to the certified clinical laboratory for testing. The collection kit is comprised of:

Blood Sample Collection Cassette
Sample Pouch
Sterile Safety Lancets (2)
Gauze Pad
Bandage (2)
Instructions for use
Prepaid Return Mailer
Patient Info Card
Outer Packaging

AI/ML Overview

Here's an analysis of the acceptance criteria and the studies performed for the Home Access® A1C Test, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in a pass/fail format with numerical targets. Instead, it describes various performance studies and their findings, which implicitly establish that the device meets certain performance expectations. The closest representation of acceptance criteria for linearity and bias are inferred from the study findings and standard guidelines.

Inferred Acceptance Criteria and Reported Device Performance:

Performance Metric	Implied Acceptance Criteria (based on CLSI guidelines & study findings)	Reported Device Performance
Precision	Within-run and total imprecision within acceptable limits for HbA1c measurement.	Within-Run Imprecision (Repeatability): - Abnormal High (12.52%): SD 0.18, CV% 1.40% - High (8.92%): SD 0.16, CV% 1.81% - Diabetic in control (6.83%): SD 0.11, CV% 1.64% - Normal (5.85%): SD 0.06, CV% 1.09% Total Imprecision: - Abnormal High: SD 0.19, CV% 1.50% - High: SD 0.27, CV% 3.00% - Diabetic in control: SD 0.27, CV% 3.93% - Normal: SD 0.16, CV% 2.69%
Linearity	Linear over the claimed assay range.	Linear over the assay range of 4.5% - 14.5% A1c. Linear fit: y = -0.0553x + 1.02, r=0.995.
Interference	Bias from tested interfering substances < 10% or < 0.75 HbA1c (whichever is smaller).	No interference (< 10% bias) from tested exogenous (Acetaminophen, Acetylsalicylic Acid, Glyburide, Ibuprofen, L-Ascorbic Acid, Metformin) and endogenous substances (Rheumatoid Factors, Triglycerides, Conjugated and unconjugated Bilirubin, Hemoglobin variants HbD and HbE). Hemoglobin variants HbS, HbC, and elevated HbF noted as potential interferents, requiring disclosure.
Limits of Detection	Reportable range established for HbA1c.	Reportable range of 4.5% to 14.5 % A1c.
Product Stability	Acceptable shelf-life and mailed sample stability.	Acceptable shelf-life for Collection Cassette and Sample Pouch: 36 months. Capillary blood samples stable for 21 days of shipping in extreme conditions.
Blood Sample Acceptability (Flex Studies)	Acceptable performance across a range of blood volumes, collection interruption times, and hematocrit levels.	- Blood Volume: As little as 30µL and as much as 500µL found acceptable. - Collection Interruption: Interruption of specimen collection up to 24 hours found acceptable. - Hematocrit Interference: Varying hematocrit levels do not interfere. - Coating Solution: Coating solution on filter paper does not interfere.
Traceability/Standardization	Traceable to IFCC reference calibrators and NGSP certified.	Traceable to IFCC reference calibrators. Certified with NGSP.
Human Factors	Lay-users able to interpret instructions, determine product appropriateness, understand cautions/warnings, and results.	Studies demonstrated lay-users were able to easily perform the required tasks and understand information.
Method Comparison	Acceptable agreement with reference method (predicate device) and adequate sample reporting rate.	- Self-collected Capillary vs. Venous Blood (combined sites): Linear Regression: -0.043 + 0.999 * X, R2 0.983 (N=127). - Professionally-collected Capillary vs. Venous Blood (combined sites): Linear Regression: -0.042 + 0.999 * X, R2 0.986 (N=127). - Average absolute bias within acceptable limits (< ±7%). - Sample adequacy for self-collected samples: 100% (0.95 CI > 97.1%).

Study Details:

2. Sample sizes used for the test set and the data provenance:

Precision Study: N=80 per HbA1c level (total N not explicitly stated but based on 2 replicates/level, 2 runs/day for 20+ days per level).
Linearity Study: 76 individually prepared dry blood samples (19 levels of HbA1c x 4 samples per level). 52 of these were capillary specimens collected from 13 volunteers. The remaining were six commercially available venous whole blood specimens, each spotted onto four Cassettes.
Interference Study: The number of samples for each interferent is not specified, only the concentration levels tested.
Product Stability (Cassette/Pouch): 53 levels of HbA1c.
Product Stability (Mailed Sample): 128 self-collected capillary blood samples.
Flex Studies:
- Blood Volume: 420 cassettes (3 HbA1c levels x 14 blood volumes/level x 10 cassettes/volume).
- Interruption: 90 cassettes (3 HbA1c levels across control and two time interval groups).
- Hematocrit: Not explicitly stated but 39 HbA1c levels with six specimens per level (2 control, 2 high Hct, 2 low Hct).
- Coating Solution: 53 levels of HbA1c.
Method Comparison: 256 patient samples (128 self-collected, 128 professionally-collected).
Data Provenance: The document does not explicitly state the country of origin for the patient data. It refers to "volunteers" and "patient samples" but no geographic location or demographic details. The studies are clinical laboratory performance studies, thus are likely for a U.S. regulatory submission. It is retrospective for the clinically collected samples (venous blood) used for comparison, and prospective for the collection of capillary blood (self-collected and professionally-collected) as part of the study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

The concept of "experts" for establishing ground truth in this context is primarily related to the analytical measurement from established, FDA-cleared laboratory systems, rather than human interpretation.

The ground truth for HbA1c values was established using FDA-cleared laboratory reagent and analysis systems, specifically the Beckman Coulter AU640e (K961274) and Beckman Coulter A1c reagents (K031380), which served as the reference method. These systems are inherently considered "expert" in their field for HBA1c measurement due to their regulatory clearance and established accuracy.
For the Human Factors Studies, the "experts" were the lay-users themselves, as the study assessed their ability to understand and use the product. The number and qualifications of these lay-users are not specified beyond being "lay-users."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

No adjudication method is described. The ground truth is based on objective laboratory measurements from a reference system.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable to this device. The Home Access® A1C Test is an in vitro diagnostic device for quantitative measurement of HbA1c, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers in that sense. There is no "AI" component, nor "human readers" interpreting images/data in a similar fashion to an MRMC study setup.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The system is a standalone algorithm/device in terms of its analytical performance. The "algorithm" here is the chemical assay and instrument processing. The testing described (precision, linearity, interference, stability, flex studies) directly assesses the performance of the device itself (collection cassette and subsequent lab analysis), which functions without human intervention during the measurement phase within the lab. However, the overall "test" involves a human (patient) for sample collection, and a laboratory for processing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth for the analytical performance studies (precision, linearity, interference, method comparison) was established by measurements obtained from an FDA-cleared predicate laboratory system (Beckman Coulter AU640e and A1c reagents) on venous blood samples. This is a reference standard measurement from a legally marketed device.

8. The sample size for the training set:

There is no explicit "training set" or "validation set" described in the context of an algorithm or AI. This is a medical device for chemical analysis. The studies described are performance verification studies for the device.

9. How the ground truth for the training set was established:

As there is no distinct "training set" in the AI/machine learning sense, this question is not applicable. The ground truth for the performance evaluations was established by the reference laboratory method as explained in point 7.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

HOME ACCESS HEALTH CORP. C/O SANDRA WHITE ICON CLINICAL RESEARCH LLC. 62 FOREST STREET SUITE 300 MARLBOROUGH MA 01752

March 13, 2015

Re: K141944 Trade/Device Name: Home Access® A1C Test Home Access® Collection Cassette Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP, JKA Dated: February 6, 2015 Received: February 9, 2015

Dear Ms. Sandra White:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -A

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K141944

Device Name Home Access® A1C Test Home Access® Collection Cassette

Indications for Use (Describe)

This test is not to be used to diagnose or screen for diabetes. Not for use on neonates.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

5. 510(K) SUMMARY

Home Access Health Corporation Home Access® A1C Test (per 21CFR 807.92)

1. SUBMITTER/510(K) HOLDER

Home Access Health Corporation 2401 West Hassell Road, Suite 1510 Hoffman Estates, IL 60169

Contact Person:
Telephone:	(847) 781-2503
Date Prepared:	March 12, 2015

2. DEVICE NAME

Proprietary Name:	Home Access® A1C Test
Common Name:	Glycosylated hemoglobin assay
Classification Name:	Assay, glycosylated hemoglobin
Regulation Number:	21 CFR §864.7470
Product Code:	LCP
Device Class:	II
Panel:	Hematology (81)
Proprietary Name:	Home Access® Collection Cassette
Common Name:	Blood specimen collection device
Classification Name:	Tubes, vials, systems, serum separators, blood collection
Regulation Number:	21 CFR §862.1675
Product Code:	JKA
Device Class:	II

3. PREDICATE DEVICES

Proprietary Name:	HemoChek-A1c Sample Collection Kit (sold under the brandReliOn A1c Test)
510(k) Number:	K990899
Classification Name:	Assay, glycosylated hemoglobin
Regulation Number:	21 CFR §864.7470
Product Code:	LCP
Device Class:	II
Panel:	Hematology (81)

{4}------------------------------------------------

4. DEVICE DESCRIPTION

This collection kit includes components needed to self-collect, package and mail a dried micro-blood sample to the certified clinical laboratory for testing. The collection kit is comprised of:

*Blood Sample Collection Cassette ●
*Sample Pouch .
*Sterile Safety Lancets (2) .
*Gauze Pad ●
. *Bandage (2)
Instructions for use ●
Prepaid Return Mailer .
Patient Info Card .
Outer Packaging .
- The Blood Sample Collection Cassette, Sample Pouch, Sterile Safety Lancets, Gauze Pad, and Bandages are identical to those submitted in 510(k) under K063852. Accessa Cholesterol Panel.

5. TESTING SERVICE DESCRIPTION

The patient/customer follows the directions to self-collect a capillary blood sample, package and mail the sample to a certified clinical laboratory for analysis. Once the cassette is received in the clinical laboratory, the dried blood sample is punched, eluted and tested using FDA-cleared laboratory reagent and analysis systems, specifically the Beckman Coulter (formerly known as Olympus) AU640e (K961274) and Beckman Coulter A1c reagents (K031380). The clinical laboratory is located at the Home Access Health Corporation facility.

6. INTENDED USE/INDICATIONS FOR USE

The Home Access® A1C Test is an in vitro test method for the quantitative measurement of Hemoglobin A1c using capillary blood collected from the fingertip, collected onto filter paper via the Home Access collection cassette. The Home Access A1C Test is for measurement of HbA1c on blood specimens which can be collected at the patient's home or in a healthcare professional setting and delivered to the laboratory by mail. Measurements obtained through this method can be used for monitoring the long-term control of blood sugar (glucose) in people with diabetes.

{5}------------------------------------------------

This test is not to be used to diagnose or screen for diabetes. Not for use on neonates.

7. COMPARISON TO PREDICATE DEVICES

The Home Access® A1C Test has technological characteristics that are substantially equivalent to the predicate device identified in the table below. Both the proposed device and the predicate device provide the patient a method to collect a capillary blood sample at home, mail the sample to a clinical laboratory, and later receive a report showing measured Hemoglobin A1c.

Among the components included with the Home Access® A1C Test is the collection cassette, comprised of two pieces of plastic housing that snap together and contain a strip of filter paper. Once the cassette is received in the clinical laboratory, the dried blood sample is punched, eluted, and tested using FDA-cleared laboratory reagent and analysis systems, specifically the Beckman Coulter (formerly known as Olympus) AU640e (K961274) and Beckman Coulter A1c reagents (K031380). The technological characteristics and intended use are substantially equivalent to the predicate device as summarized in the following table:

DeviceFeatures	Home Access® A1C Test	K990899HemoChek A1c Sample Collection Kit
Indication forUse	The Home Access® A1C Test is an in vitro testmethod for the quantitative measurement ofHemoglobin A1c using capillary blood collectedfrom the fingertip, collected onto filter paper viathe Home Access collection cassette. The HomeAccess A1C Test is for measurement of HbA1con blood specimens which can be collected at thepatient's home or in a healthcare professionalsetting and delivered to the laboratory by mail.Measurements obtained through this method canbe used for monitoring the long-term control ofblood sugar (glucose) in people with diabetes.This test is not to be used to diagnose or screenfor diabetes. Not for use on neonates.	The HemoChek-A1c Sample collection Kit isindicated for over-the-counter sale for use in themeasurement of HbA1c on blood specimenswhich can be collected at the patient's home orat a physician's office on filter paper anddelivered to the laboratory by mail. The HbA1ctest is used in the assessment of the averageblood glucose over a 10-12 week period. Theresults are to be evaluated by the patient andtheir physician. The product is not indicated fordiagnosis of diabetes mellitus.
KitComponents	Blood Sample Collection Cassette containingfilter paper for specimen collectionSample Pouch with desiccant for specimenpackaging2 Sterile Safety lancetsGauze Pad2 BandagesInstructions for Use/Things You Should KnowAbout A1CPrepaid Return Mailer for specimen mailingPatient Info Card for specimen labeling andconsentOuter Packaging	Collection InstructionsA1c Test Authorization & Collection FormSterile LancetAlcohol PadGauze PadAdhesive BandagePostage Paid Return Envelope

{6}------------------------------------------------

DeviceFeatures	Home Access® A1C Test	K990899HemoChek A1c Sample Collection Kit
SamplePreparation	Lay user independent. Finger stick bloodcollected on a filter paper within the cassette.	Lay user independent. Finger stick bloodcollected on Collection Form (filter paper card).

8. PERFORMANCE TESTING

The following standards/guidance documents were used in the design and testing of the Home Access® A1C Test.

StandardsNo.	StandardsOrganization	Standards title
EP05-A2	CLSI	Evaluation of Precision Performance of Quantitative measurement Methods;Approved Guideline-Second Edition. August 2004
EP6-A	CLSI	Evaluation of the Linearity of Quantitative Measurement Procedures: AStatistical Approach; Approved Guideline. April 2003.
EP07-A2	CLSI	Interference Testing In Clinical Chemistry; Approved Guideline-SecondEdition.
EP09-A2-IR	CLSI	Method Comparison and Bias Estimation using PatientSamples; Approved Guideline – Second Edition (Interim Revision)
EP17-A2	CLSI	Evaluation of Detection Capability for Clinical Laboratory MeasurementProcedures; Approved Guideline- Second Edition.
EP25-A	CLSI	Evaluation of Stability of in vitro Diagnostic Reagents; Approved Guideline.
C44-A	CLSI	Harmonization of Glycohemoglobin Measurements. Approved Guideline.December 2002.
N/A	FDA Guidance	Review Criteria for Assessment of Glycohemoglobin (Glycated orGlycosylated) Hemoglobin in vitro Diagnostic Devices

a. Precision

A Precision study was performed following CLSI EP05-A2, Evaluation of Precision Performance of Clinical Chemistry Devices. Three (3) levels of HbA1c, eluted from dried blood spots (referred to as Micro-blood samples or "MBS") were tested, 2 replicates per level per run, 2 runs per day for at least 20 days. The results are shown below.

Sample(MBS)N=80	HbA1c Mean(HbA1c%)	Within-Run Imprecision, orRepeatability		TotalImprecision
		SD	CV%	SD	CV%
Abnormal High	12.52	0.18	1.40%	0.19	1.50%
High	8.92	0.16	1.81%	0.27	3.00%
Diabetic in control	6.83	0.11	1.64%	0.27	3.93%
Normal	5.85	0.06	1.09%	0.16	2.69%

Precision Summary

b. Linearity

Linearity was assessed following CLSI EP6-A, Evaluation of the Linearity of

{7}------------------------------------------------

Nineteen (19) levels of HbA1c ranging from 4.5 to 15.9 %A1c were tested in this study, with 4 individual samples at each level, or 76 individually prepared dry blood samples (19 levels of HbA1c x 4 samples per level). Out of these 76 samples. 52 (13 x 4) samples were collected as capillary specimens from 13 volunteers.

These capillary samples were supplemented with six commercially available venous whole blood specimens. Each whole blood specimen was spotted onto four MBS Collection Cassettes.

The linear fit for HbA1c was: y = -0.0553x + 1.02, r=0.995. The assay was determined to be linear over the assay range of 4.5% - 14.5% A1c.

c. Interference

Interference was assessed following EP07-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline- Second Edition. Studies were performed to assess common or known exogenous and endogenous substances that could interfere with the Home Access® A1C Test. The exogenous substances tested were Acetaminophen, Acetylsalicylic Acid, Glyburide, Ibuprofen, L-Ascorbic Acid, and Metformin, and the endogenous substances were: Rheumatoid Factors, Triglycerides, Bilirubin (conjugated and unconjugated) and Hemoglobin variants (HbC, HbD, HbE, HbF and HbS).

Interference was calculated as the difference between (a) measurement of blood specimens with interferent as compared to (b) measurement of control group specimens without interferent. Interference is claimed when the difference is equal to or exceeds 0.75 HbA1c (%) and/or 10%, whichever is smaller.

Based on the results of this study, the Home Access® A1C Test does not show interference, all levels tested showed < 10% bias from the following exogenous substances:

Acetaminophen up to 20 mg/dL ●
Acetylsalicylic Acid up to 65 mg/dL ●
Glyburide up to 0.2 mg/dL
Ibuprofen up to 50 mg/dL ●
. L-Ascorbic Acid up to 3 mg/dL
Metformin up to 4 mg/dL ●

and endogenous substances:

{8}------------------------------------------------

Rheumatoid Factors up to 600 IU/ml
Triglycerides up to 1640 mg/dL
Conjugated and unconjugated Bilirubin up to 30 mg/dL .
Hemoglobin variants (HbD and HbE) ●

The Home Access® A1C Test is suitable for adoption in the laboratory, with the appropriate disclosure in the labeling that Hemoglobin Variants HbS, HbC and elevated HbF have been known to interfere with test results.

The following limitation will be placed in the Home Access® A1C Test labeling (package insert and front of box labeling):

"A1C tests are not reliable for monitoring blood sugar in people with hemoglobin variants. Ask your Doctor if you have Hemoglobin S, Hemoglobin C or elevated Hemoglobin F. These variants have been shown to interfere with this A1c Test. Do not use this test if you have these variants."

d. Limits of Detection

Limits of detection were assessed following CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition.

The test has a reportable range of 4.5% to 14.5 % A1c.

e. Product Stability

Using CLSI EP 25-A, Evaluation of Stability of in vitro Diagnostic Reagents; Approved Guideline and CLSI EP09-A2-IR Method Comparison and Bias Estimation using Patient Samples; Approved Guideline - Second Edition (Interim Revision), the difference in test results using aged Collection Cassettes and Sample Pouches was evaluated. Fifty-three (53) levels of HbA1c covering the measuring range were evaluated. This study demonstrated the acceptable shelf-life for the Collection Cassette and Sample Pouch of 36 months.

Mailed Sample Stability was assessed following the format of CLSI EP 25-A, Evaluation of Stability of in vitro Diagnostic Reagents; Approved Guideline and CLSI EP09-A2-IR Method Comparison and Bias Estimation using Patient Samples; Approved Guideline - Second Edition (Interim Revision).

One hundred twenty eight (128) self-collected capillary blood samples were compared to venous blood. Samples covered the HbA1c measuring range. Patient

{9}------------------------------------------------

capillary blood samples were shown to be stable for 21 days of shipping in extreme conditions.

f. Flex Studies

Flex studies were conducted to assess any potential pre-analytical error that could be obtained from blood samples by the testing laboratory. These studies evaluated blood sample acceptability in terms of:

(a) the minimum and maximum blood volume collected in the Collection Cassette,
interruption in collection of blood drops in the Collection Cassette (b)
an evaluation of potential interference of Hematocrit with the Home Access® (c) A1C Test and
(d) whether coating solution on the filter paper interfered with HbA1c testing in capillary micro-blood samples

Results of Flex Studies. For minimum and maximum blood sample acceptability, three (3) HbA1c levels were tested with fourteen (14) blood volumes per level. There were 10 cassettes per volume of blood, 420 cassettes in total. This study demonstrated that as little as 30ul and as much as 500ul could be collected and the sample would still be acceptable.

For the timing (interruption) study, three (3) HbA1c levels were tested using 90 cassettes (total) spread evenly over control group, and two time interval groups. This study demonstrated that interruption of specimen collection could be as long as 24 hours and the sample would still be acceptable.

The Hematocrit interference study used 39 HbA1c levels ranging from 4.8% to 12.4% of the Home Access® A1C Test, six specimens per level: two each of control, or "normal" hematocrit, specimens, high hematocrit and low hematocrit. The study demonstrated that varying hematocrit levels do not interfere with the Home Access® A1C Test.

The Study to evaluate whether using coating solution on filter paper interfered with HbA1c testing in capillary micro-blood samples included specimens collected using coated filter paper, and specimens collected using uncoated filter paper. The study used 53 levels of HbA1c covering the range of 4.8% to 12.4% (approximating the measuring range of the Home Access® A1C Test). The study determined that the coating solution does not interfere with the testing and the results of HbA1c in micro-blood samples.

{10}------------------------------------------------

g. Traceability and Expected Values (Controls, Calibrators, or Methods):

The Home Access® A1C Test standardization is traceable to the IFCC reference calibrators. The Home Access® A1C Test is certified with the National Glycohemoglobin Standardization Program (NGSP). The NGSP certification expires in one year. See NGSP website for current certification at http://www.ngsp.org.

The derived result of the ratio (%) from the NGSP correlation is calculated from the individual quantitative results for total hemoglobin (THb) and Hemoglobin A1c. The International Federation of Clinical Chemistry (IFCC) units of mmol/mol are calculated using the Master Equation:

IFCC= (NGSP-2.15)/0.092

h. Human Factors Studies

Human factor studies demonstrated that lay-users were able to easily (a) interpret instructions, (b) determine if the product was appropriate for their purchase and use, (c) understand the relevance of cautions and warnings included in the product labeling, and (d) understand their results.

Method Comparison i.

Method comparison was assessed following CLSI EP09-A2-IR, Method Comparison and Bias Estimation using Patient Samples; Approved Guideline - Second Edition (Interim Revision), using 256 patient samples (128 self-collected and 128 professionally-collected) spanning the assay measuring range of 4.5 - 14.5% HbA1c and compared to expected, or whole blood samples from venous blood draw, measured with the predicate device - Beckman Coulter Hemoglobin A1c Test (K031380).

The study demonstrated the new Home Access A1C Test was acceptable for measuring HbA1c. All 128 patients were able to self-collect enough blood to have an adequate sample. Consequently, 128 (or 100%) of self-collected capillary blood samples provided reportable results: the sample adequacy for self-collected samples was 100% (0.95 CI > 97.1%). One (1) single specimen result was outside of the measuring range.

An average absolute bias and related confidence interval were well below the acceptable limits of + 7%. The results are presented below.

{11}------------------------------------------------

Comparison	Number ofSamples	Linear Regression	R2	Sample RangeTested
Self-collected Capillary vs.Venous Blood at Site 1	107	$-0.032 + 0.997 * X$	0.984	4.8-13.9
Self-collected Capillary vs.Venous Blood at Site 2	20	$0.053 + 0.993 X$	0.97	5.9-13.1
Self-collected Capillary vs.Venous Blood (combined sites)	127	$-0.043 + 0.999 * X$	0.983	4.8-13.9

A comparison of Self-collected Capillary Blood vs. Venous Blood:

A comparison of Professionally-collected Capillary Blood vs. Venous Blood:

Comparison	Number ofSamples	Linear Regression	R2	Sample RangeTested
Professional Capillary vs.Venous Blood at Site 1	107	$0.100 + 0.976 * X$	0.984	4.8-13.9
Professional Capillary vs.Venous Blood at Site 2	20	$-0.196 + 1.032 * X$	0.992	5.9-13.1
Professional Capillary vs.Venous Blood (combined sites)	127	$-0.042 + 0.999 * X$	0.986	4.8-13.9

9. CONCLUSIONS DRAWN

Based on the comparison of technological features and intended use, and as a result of the performance testing completed on the Home Access® A1C Test, the proposed device does not raise new questions of safety and effectiveness and supports the conclusion that the proposed device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 864.7470 Glycosylated hemoglobin assay.

(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).