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The intended use of the AccuBase Arc Test Kit is for the determination of the relative percent (%) A16 (glycohemoglobin) in human whole blood (capillary) samples, using high performance liquid chromatography (HPLC) as the analytical method.

The AccuBase A1c Test Kit will be available to diabetes patients through physicians, pharmacies, diabetes supply and/or OTC distribution companies for the purpose of monitoring the average glucose ooncentration in the body over the past 30, 60 or 90 days including; a calculated Mean Blood Glucose (MBG) determination based on the DCCT MBG equation (31.7 X Arc % - 66.1) == MBG mg/dl as part of an comprehensive individual diabetes outcomes management, glycemic status assessment and treatment program.

The AccuBasc Are Test Kit does not replace daily blood giucose monitoring.

While there are no known contraindications, it is well known that the existence of disturbed erythrocyte kinetics conditions (such as anemia) many result in a non-reportable test result duc to too few Red Blood cells per volume of sample. A list of potential confounding factors are reported on the test result at time of reporting. Keep out of reach of children and pets.

The intended reporting path of the AccuBase Ate test Kit test result include direct reporting to patients and/or a healthcare professional. Test results must be provided to a physician and/or healthcare professional for interpretation of specific A1e values and setting of specific target Air goals.

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This document is a 510(k) premarket notification approval letter for the Accu-Base A1c Test Kit. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The provided text primarily focuses on regulatory approval, intended use, and general guidance for the applicant.

Therefore, I cannot extract the requested information from the provided document.

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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.

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.

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

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.

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