ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT by DIABETES TECHNOLOGIES, INC. (DTI)

The intended use of the Accu-Base Hemoglobin Arc Sample Indications for Use: Collection Kit is for the determination of the relative percent (%) hemoglobin Arc in human whole blood (capillary) samples, using high performance liquid chromatography (HPLC)as the analytical method.

The Accu-Base Hemoglobin Arc Sample Collection Kit will be available to patients through Point of Care Offices and/or Centers, for the purpose of monitoring individual, long-term diabetes control as part of a comprehensive diabetes management & treatment program.

The Accu-Base Hemoglobin Arc Sample Collection Kit does not replace daily blood glucose monitoring.

There are no known contraindications. Keep out of reach of children.

The intended reporting path of the HbAic test results include direct reporting to the physician/health care professional responsible for the care of the individual for clinical interpretation including setting and interpreting specificHbArc target goals and test results. In addition the results may be reported to the patient.

Device Description

The Accu-Base Hemoglobin Are Sample Collection Kit is packaged in two sizes or configurations designed for professional use. One kit is designed for patient take home use and is available in a one (1), two (2) and three (3) test kit configuration. The other, the (Point of Care Kit) is designed with ten (10) tests for in-office use. The Point of Care Kit is ideal for the physician's office, clinic, small hospital and/or diabetes clinic and/or laboratory.

The at-home kit is designed to be used by qualified patients (physician discretion) in the privacy and convenience of their home. The at-home kit is designed to facilitate the collection, preparation, storage and transport of capillary (fingerstick) hemoglobin Are patient samples for laboratory analysis while providing empowerment and self-management training for the patient. The kit contains sufficient supplies and materials to collect either 1, 2 or 3 individual HbAic patient samples including:

1 durable self-contained shipper with built in labeled workstation.

1, 2 or 3 vials of (1 ml of hemolysis reagent),

1 capillary tube holder,
2-5 Na Heparinized 5ul capillary tubes (in labeled capillary dispenser) depending on the actual number of tests in the kit.

1-3 biohazard specimen bags with absorbent pads for airtight sample transport.

1-3 positive patient ID laboratory forms with peel off ID labels that are attached to the hemolysis vials (sample preparation vials).

1-3 sample mailers (pre-addressed/postage paid) to designated laboratory.

Kit contents continued:

1 patient size HbAıc longitudinal tracking log. Product insert (Information & Instructions Booklet) 1 Mean Blood Glucose Monitoring Journal Toll free (24 hour) technical assistance line 888-872-2443

Note: Once the sample is collected and prepared, the Red Blood Cells (sample) Are hemolyzed. Schiff base removed and the sample is preserved for analysis and/or freezing for future analysis.

in both cases, the finger, ear lobe or heal (pediatric patient/infants), is pierced (lanced) using a traditional sterile, disposable lancet device (SafeLet). The patient and/or care provider is instructed to lance the finger, wipe away the first drop, milk the finger toward the puncture site and collect the second drop of blood. A capillary tube is attached to a capillary tube and is filled with whole blood from the finger, the tube is filled from end to end (approximately 5ul of blood). The capillary tube is than wiped of any excess blood and placed in the open vial containing the hemolysis reagent.

The vial is closed tightly and gently rotated to mix the sample with the hemolysis reagent (ensuring that all of the blood has transferred from the capillary tube to the surrounding reagent. (no blood or RED line will be visible in the tube once the vial has been properly mixed. The solution will be a heterogeneous light to dark pink color). The vial is labeled using the peel off label provided on the Patient Identification Form (sequenced number specific to that sample that are nonrepeating numbers).

The lab form ID number corresponds to the vial number for positive ID at the laboratory. The labeled and mixed sample is placed in a biohazard bag, which also contains instructions for use to ensure proper sample processing. The bag is sealed using self-adhesive tape to ensure an airtight seal of the specimen during transport. The sealed biohazard bag is then placed in the sample mailer along with the lab ID form and closed with sealing tape to ensure safe undisturbed transport of the sample to the designated laboratory.

The patient's sample can be dropped in the mail as soon as collected and prepared or placed in the refrigerator overnight if the sample is not going to be mailed the same day. The sample is stable for up to 14 days at room temperature and up to 21 days at refrigerated temperatures. The sample is considered pretreated and incubated when it arrives in the testing laboratory and can be immediately analyzed without any further treatment, dilution, elution or preparation. The lab verifies the patient name and ID number and performs the test using an automated Bio-Rad Laboratories HPLC instrument such as the MDMD™, Variant™ or Diamat™ system).

The Point of Care (10 test kit), professional use kit is designed for low volume hospitals, clinical and large volume doctors offices. The kit includes sufficient supplies and materials to collect and process 10 samples. The kit includes patient chart size HbAıc tracking logs, The kits contain all of the supplies found in the smaller kits contained in a larger storage kit with the same printed instructions for use.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Accu-Base Hemoglobin A1c Sample Collection Kit:

The provided text describes a medical device, the Accu-Base Hemoglobin A1c Sample Collection Kit, and its 510(k) submission for substantial equivalence to predicate devices. The study detailed focuses on demonstrating the equivalence of capillary blood samples collected with the kit compared to traditional venipuncture for HbA1c measurement.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Correlation with Venipuncture (Adults & Children)	0.99218 (excellent correlation)
Precision of Home vs. Lab Collected Samples	"Very acceptable" (qualitative assessment)
User Acceptance/Perception	90% preferred at-home kit over venipuncture
Correlation of Mean ± SD A1c (LAB vs. KIT)	LAB: 8.1 ± 1.9; KIT: 8.3 ± 1.7 (p=NS - not statistically significant)
Agreement between Capillary and Venous HbA1c (Second Feasibility Study)	Capillary: 0.959; Venous: 0.494; R² = 98.7% (excellent agreement)
Accuracy of Collection System (Feasibility Study)	"Accurate"
Stability of Collection System (Feasibility Study)	"Stable"
Simplicity of Use of Collection System (Feasibility Study)	"Simple to use"

Note on Acceptance Criteria: The document primarily focuses on demonstrating strong correlation and agreement with established venipuncture methods and user acceptance, rather than explicitly stating pre-defined numerical "acceptance criteria" in the way a clinical trial protocol might. The reported performance metrics are presented to show the device's reliability and usability.

2. Sample Size Used for the Test Set and Data Provenance

Test Set 1 (Precision and Accuracy Study):
- Sample Size: 48 patients (adults and children with diabetes).
- Data Provenance: Prospective, conducted at the Diabetes Research Institute at the University of Miami (USA). This study compared capillary samples collected with the kit to traditional venipuncture using the same analytical system.
Test Set 2 (Clinical Trial & Field User Evaluation):
- Sample Size: 100 patients.
- Data Provenance: Prospective, conducted at the Tulane Endocrine Clinic (USA) over several months.
Test Set 3 (Additional Feasibility Clinical Trials):
- Sample Size: Not explicitly stated, but implies a cohort was used to generate the reported R² value.
- Data Provenance: Prospective, conducted at the Park Nicollet Medical Center and The International Diabetes Center in Minneapolis (USA).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts or their qualifications for establishing ground truth in the traditional sense of consensus or adjudication. The "ground truth" used for comparison appears to be:

HbA1c values obtained from traditional venipuncture samples. These samples would have been analyzed by qualified laboratory personnel using established and validated methods (Bio-Rad Diamat reagent analytical system and HPLC).
User feedback/perception. This was gathered during the field user evaluation, likely through questionnaires or interviews with the 100 patients.

Therefore, the "experts" in this context are the medical and laboratory professionals performing the venipuncture and lab analysis, and indirectly, the patients themselves providing expert feedback on usability.

4. Adjudication Method for the Test Set

No formal adjudication method (e.g., 2+1, 3+1) is described for the test set. The ground truth was established by comparing the HbA1c results from the kit's capillary samples directly against results from the established venipuncture method, performed at reputable medical/research institutions. User feedback was collected directly from patients.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This device is a sample collection kit and not an AI-powered diagnostic algorithm that requires multiple human readers for interpretation. The comparison is between different sample collection methods (capillary vs. venipuncture) and user experience.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a sample collection kit, not a standalone algorithm. Its performance is tied to the reliability of the collected sample and its compatibility with standard laboratory analytical equipment (HPLC).

7. Type of Ground Truth Used

The primary ground truth used was:

Comparator Method / Established Clinical Standard: HbA1c values obtained from traditional venipuncture blood samples analyzed by established, validated laboratory methods (Bio-Rad Diamat reagent analytical system and HPLC).
User Experience (Qualitative): Patient feedback and preferences regarding the at-home kit compared to venipuncture.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. This device does not appear to employ an algorithm that requires a training phase. The studies described are for validation of the collection kit's performance rather than training a model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for an algorithm.

Summary

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NOV 30 1998

1983172

Summary of Safety and Effectiveness

Submitter:

Diabetes Technologies, Inc. 216 west Jackson Street Thomasville, GA 31792 Phone: 912-227-1752 FAX: 912-227-0827

Contact Person: Arthur G. Williams President

September 1, 1998 Date Prepared:

Product Trade Name: Accu-Base Hemoglobin Air Sample Collection Kit.

Glycohemoglobin (HbAıc) Test Kit Common Name;

Glycated Hemoglobin Assay (21 C.F.R. 864.7470 and Classification name: 81LCP

Predicate Device:

A1c-CHEK (HbA1c-1), K973365, Express Med, Inc., 1.
EZCHEK™/HbAic Sample Collection Kit, FLEXSITE 2. Diagnostics, Inc., K971919
Self Assure/GHb, Awareness Technology, Inc., 3. K861697A
Diamat Glycosylated Hemoglobin analyzer 4. Reagent System, Bio-Rad laboratories., K851636

1 durable self-contained shipper with built in labeled workstation.

1, 2 or 3 vials of (1 ml of hemolysis reagent),

1 capillary tube holder,
2-5 Na Heparinized 5ul capillary tubes (in labeled capillary dispenser) depending on the actual number of tests in the kit.

1-3 biohazard specimen bags with absorbent pads for airtight sample transport.

1-3 positive patient ID laboratory forms with peel off ID labels that are attached to the hemolysis vials (sample preparation vials).

1-3 sample mailers (pre-addressed/postage paid) to designated laboratory.

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Summary of Safety and Effectiveness Diabetes Technologies, Inc.

Kit contents continued:

1 patient size HbAıc longitudinal tracking log. Product insert (Information & Instructions Booklet) 1 Mean Blood Glucose Monitoring Journal Toll free (24 hour) technical assistance line 888-872-2443

Note: Once the sample is collected and prepared, the Red Blood Cells (sample) Are hemolyzed. Schiff base removed and the sample is preserved for analysis and/or freezing for future analysis.

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Summary of Safety and Effectiveness Diabetes Technologies, Inc.

It is further intended that the copies of the patient's results may be sent to the patient, physician and other entities as directed and approved by the physician and patient includina: insurance and managed care companies to whom these individuals are current members as part of a more comprehensive outcomes measurement program for diabetes.

Ordering of the kit for patient at-home use is determined by the physician qualifying the patient and/or care provided as to the individuals motivation to participate in self-management, their literacy level to follow written and visual instructions, visual impairment assessment (sight level), mental impairment assessment and physical impairment as well as their dexterity to complete the required collection steps.

Intended use of the kit includes HbAic samples from children (pediatrics) ages one and older (special consideration to hemoglobin F) is determined using HPLC during the first vear of life. While the kit is designed for use in children, it is not recommended to be collected by children and therefore a KEEK OUT OF REACH OF CHILDREN label is posted on the kit.

The level of sample collection complexity can and should be compared to the use of a alucose meted by individuals with diabetes that are currently using and comfortable with using a SMBG Blood Glucose Meter.

In the case where a child, visually, mentally impaired or physically challenged individual is to have a sample collected at-home, a third person that has been trained and/or qualified on the use of the kit is responsible for assisting the patient with the sample collection. Easy to follow instruction and a toll free help line is available for these or any individual that requests assistance. In addition, the sample can be drawn (collected) by any health care professional, clinical laboratory, visiting nurse, and home health agency. Once the patient has been aualified to collect the sample at-home. follow-up kits can be automatically shipped to the patient as reauired (directed) by the physician.

To establish substantial equivalence to an existing (predicate device), and thus establish the Safety and Effectiveness of the Accu-Base Hemoglobin A ic Sample Collection kit, capillary samples were first compared to the traditional venipuncture method in adults and children with diabetes using the same Bio-Rad Diamat reagent analytical system and method (HPLC venous to capillary comparison). The 48 patient precision and accuracy study was preformed at the Diabetes Research Institute at the University of Miami. As the data indicates excellent correlation was achieved (0.99218). An additional 100 patient Clinical Trial (including a field user evaluation) was preformed with patients from the Tulane Endocrine Clinic over a several month period. The results were considered very acceptable for both precision of home to lab collected samples as well as the user feedback as to their acceptance and perception of the kit. 90% of patient's preferred the at-home kit over venipuncture and the clinical data

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Summary of Safety and Effectiveness Diabetes Technologies, Inc.

revealed excellent correlation of Mean ± SD A 1 c was 8.1 ± 1.9 LAB and 8.3 ± 1.7 KIT (p=NS).

The analytical method used in the kit is the NIH reference method and can detect Hemoglobinopathies and abnormal RBC conditions such as anemia.

Additional feasibility clinical trials were conducted at the Park Nicollet Medical Center and The International Diabetes Center in Minneapolis that resulted in the clinical conclusion that the collection system is accurate, stable and simple to use. Their clinical results revealed "excellent agreement between the capillary and venous HbAic values, (capillary 0.959, venous + 0.494, R 2 = 98.7%).

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized symbol of three human profiles facing right, stacked on top of each other, with the top profile being the most prominent.

NOV 30 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Arthur G. Williams President DIABETES TECHNOLOGIES, INC. 216 West Jackson Street Thomasville, GA 31792

Re: K983172 Trade Name: Accu-Base Hemoglobin A1c Sample Collection Kit Regulatory Class: II Product Code: 81 LCP Dated: September 1, 1998 Received: September 10, 1998

Dear Mr. Williams:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Intended Use

K 983172 510 (k) Number (if known)

Accu-Base Hemoglobin Arc Sample Collection Kit Device Name:

The intended use of the Accu-Base Hemoglobin Are Sample Indications for Use: Collection Kit is for the determination of the relative percent (%) hemoglobin Arc in human whole blood (capillary) samples, using high performance liquid chromatography (HPLC)as the analytical method.

The Accu-Base Hemoglobin Arc Sample Collection Kit will be available to patients through Point of Care Offices and/or Centers, for the purpose of monitoring individual, long-term diabetes control as part of a comprehensive diabetes management & treatment program.

The Accu-Base Hemoglobin Arc Sample Collection Kit does not replace daily blood glucose monitoring.

There are no known contraindications. Keep out of reach of children.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDHR, Office of Device Evaluation (ODE)

Prescription Use 2 (Per 21 CFR 801.109)

OR Over-The Counter Use

e.g., Home use by prescription.

Aim

(Division Sign-Off)

ivision of Clinical Laborator 510(k) Number

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).