(239 days)
No
The summary describes a blood collection kit and laboratory test for HbA1c. There is no mention of AI/ML in the device description, intended use, performance studies, or any other section. The performance studies focus on analytical and clinical validation of the laboratory test method, not on algorithmic performance.
No
The device is an in vitro diagnostic test for monitoring blood sugar levels, not for providing therapy or treatment.
No
The device is for monitoring long-term blood sugar control in people with diabetes, but the "Intended Use" explicitly states: "This test is not to be used to diagnose or screen for diabetes."
No
The device description clearly lists physical components like a collection cassette, lancets, gauze, bandages, and packaging, indicating it is a hardware-based medical device for sample collection.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is an "in vitro test method for the quantitative measurement of Hemoglobin A1c using capillary blood collected from the fingertip". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: It uses capillary blood, which is a biological specimen collected from the body for analysis.
- Measurement: It performs a "quantitative measurement" of Hemoglobin A1c, which is a specific analyte in the blood.
- Purpose: The measurements are used for "monitoring the long-term control of blood sugar (glucose) in people with diabetes," which is a medical purpose.
- Device Description: The description details a "micro-blood specimen collection kit" intended to "facilitate in vitro laboratory testing".
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of a potential recipient with a potential donor, or to monitor therapeutic measures.
N/A
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 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.
Product codes
LCP, JKA
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip (for capillary blood collection)
Indicated Patient Age Range
Not for use on neonates.
Intended User / Care Setting
Can be collected at the patient's home or in a healthcare professional setting and delivered to the laboratory by mail.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
a. Precision
Study Type: Precision study following CLSI EP05-A2, Evaluation of Precision Performance of Clinical Chemistry Devices.
Sample Size: Not specified directly for samples, but refers to "3 levels of HbA1c, eluted from dried blood spots (...) tested, 2 replicates per level per run, 2 runs per day for at least 20 days."
Key Results:
- Abnormal High: HbA1c Mean = 12.52%, Within-Run SD = 0.18, CV% = 1.40%, Total SD = 0.19, CV% = 1.50%
- High: HbA1c Mean = 8.92%, Within-Run SD = 0.16, CV% = 1.81%, Total SD = 0.27, CV% = 3.00%
- Diabetic in control: HbA1c Mean = 6.83%, Within-Run SD = 0.11, CV% = 1.64%, Total SD = 0.27, CV% = 3.93%
- Normal: HbA1c Mean = 5.85%, Within-Run SD = 0.06, CV% = 1.09%, Total SD = 0.16, CV% = 2.69%
b. Linearity
Study Type: Linearity assessment following CLSI EP6-A.
Sample Size: 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.
Key Results: 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
Study Type: Interference assessment following EP07-A2.
Key Results: The Home Access® A1C Test does not show interference, all levels tested showed 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%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Linear Regression: y = -0.0553x + 1.02, r=0.995 (for Linearity)
Precision: SD and CV% values provided for different HbA1c levels.
Bias: 97.1%) (Method Comparison).
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
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.
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 brand
ReliOn 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
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 .
-
- 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:
| Device
Features | Home Access® A1C Test | K990899
HemoChek A1c Sample Collection Kit |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication 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.
This test is not to be used to diagnose or screen
for diabetes. Not for use on neonates. | The HemoChek-A1c Sample collection Kit is
indicated for over-the-counter sale for use in the
measurement of HbA1c on blood specimens
which can be collected at the patient's home or
at a physician's office on filter paper and
delivered to the laboratory by mail. The HbA1c
test is used in the assessment of the average
blood glucose over a 10-12 week period. The
results are to be evaluated by the patient and
their physician. The product is not indicated for
diagnosis of diabetes mellitus. |
| Kit
Components | Blood Sample Collection Cassette containing
filter paper for specimen collection
Sample Pouch with desiccant for specimen
packaging
2 Sterile Safety lancets
Gauze Pad
2 Bandages
Instructions for Use/Things You Should Know
About A1C
Prepaid Return Mailer for specimen mailing
Patient Info Card for specimen labeling and
consent
Outer Packaging | Collection Instructions
A1c Test Authorization & Collection Form
Sterile Lancet
Alcohol Pad
Gauze Pad
Adhesive Bandage
Postage Paid Return Envelope |
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| Device
Features | Home Access® A1C Test | K990899
HemoChek A1c Sample Collection Kit |
|-----------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Sample
Preparation | Lay user independent. Finger stick blood
collected on a filter paper within the cassette. | Lay user independent. Finger stick blood
collected 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.
| Standards
No. | Standards
Organization | 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: A
Statistical Approach; Approved Guideline. April 2003. |
| EP07-A2 | CLSI | Interference Testing In Clinical Chemistry; Approved Guideline-Second
Edition. |
| EP09-A2-IR | CLSI | Method Comparison and Bias Estimation using Patient
Samples; Approved Guideline – Second Edition (Interim Revision) |
| EP17-A2 | CLSI | Evaluation of Detection Capability for Clinical Laboratory Measurement
Procedures; 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 or
Glycosylated) 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, or
Repeatability | | Total
Imprecision | |
|-------------------------|------------------------|---------------------------------------------|-------|----------------------|-------|
| | | 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 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 of
Samples | Linear Regression | R2 | Sample Range
Tested |
|---------------------------------------------------------------|----------------------|----------------------|-------|------------------------|
| 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 of
Samples | Linear Regression | R2 | Sample Range
Tested |
|-------------------------------------------------------------|----------------------|----------------------|-------|------------------------|
| 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.