The Precision A1c Home HbA1c Sample Collection Kit is intended to be a home-use or office-use device for the collection of a capillary blood sample on a blood sample collection card for in vitro diagnostic laboratory evaluation of the amount of HbA1c (glycosylated hemoglobin). This collection device will be used to monitor long-term blood glucose control in patients with diabetes mellitus.

The Precision Alc sample collection device will be marketed over-the-counter. This kit is not indicated for the diagnosis of diabetes mellitus.

Device Description

The Precision A1c Home HbA1c Sample Collection Kit contains the materials necessary to collect a capillary blood sample from a finger-stick to a piece of filter paper and mail it to a clinical laboratory for the determination of percent hemoglobin A1c (also known as glycohemoglobin or glycosylated hemoglobin).

The Precision A1c sample collection kit contains a lancet, patient information sheet, instruction sheet, alcohol pad, gauze pad, bandage, pre-paid mailing envelope, and a blood sample collection card (inside a zip-locked foil pouch containing a desiccant).

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance for Precision A1c™ Home HbA1c Sample Collection Kit (K983253)

The key performance criteria for the Precision A1c™ Home HbA1c Sample Collection Kit are based on the correlation and agreement of HbA1c results obtained from samples collected with the kit compared to whole blood samples. The study assessed the performance of the device when used by both trained operators and lay users.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria values (e.g., "correlation coefficient must be > 0.95"). However, the language of the conclusion, stating "Results indicate excellent correlation... and equivalent results," strongly implies that the observed performance values were considered acceptable. Based on the data presented and the concluding remarks, the implied acceptance criteria would generally be a correlation coefficient close to 1.000, a slope close to 1.000, and a y-intercept close to 0.0, along with low bias and Sy.x values.

Metric	Implied Acceptance Goal (Based on "excellent correlation" and "equivalent")	Trained Operator vs. Whole Blood	Lay User vs. Whole Blood	Trained Operator vs. Lay User
Correlation Coefficient	Close to 1.000	0.993	0.989	0.996
Slope	Close to 1.000	1.019	1.016	0.999
y-Intercept	Close to 0.0	-0.02	-0.05	-0.04
Sy.x	Low (e.g., < 0.3)	0.22	0.27	0.18
Bias	Low (e.g., close to 0.0)	0.12	0.07	-0.05
Mean Absolute % Bias	Low (e.g., < 3%)	2.50	2.77	1.76
N (Sample Size)	Sufficient for statistical significance (minimum of 258/259 met)	258	259	259

2. Sample Size for the Test Set and Data Provenance

Sample Size:
- Trained Operator vs. Whole Blood: N = 258
- Lay User vs. Whole Blood: N = 259
- Trained Operator vs. Lay User: N = 259
Data Provenance:
- The study involved clinical sites, and samples were collected from patients. However, the specific country of origin is not explicitly stated. The document refers to "LabOne" and "University of Missouri," suggesting the data is likely from the United States.
- The study appears to be prospective in nature, as it describes the collection of samples specifically for the performance evaluation from patients, followed by parallel analysis.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

The establishment of ground truth in this study relies on established laboratory instruments and methods rather than individual expert interpretation of complex images or clinical cases.

Number of Experts: Not applicable in the traditional sense of medical imaging or diagnostic interpretation by human experts.
Qualifications of Experts: The "ground truth" reference measurements were performed by laboratory instruments (Roche Cobas Integra, HbA1c Cassette; Roche Cobas Mira, Unimate Reagent; Bio-Rad Diamat Glycosylated Hemoglobin Analyzer System) at clinical laboratories (LabOne and University of Missouri). These laboratories are assumed to be operating under standard clinical laboratory practices with qualified personnel.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by laboratory instrument readings, not by a consensus of human reviewers.

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

No, an MRMC comparative effectiveness study was not done. This study is focused on the performance of a sample collection device, not on diagnostic accuracy of human readers with or without AI assistance. The comparison is between different sample collection methods and operators, with a reference to a laboratory analyzer.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device. The study evaluates the performance of the Precision A1c Home HbA1c Sample Collection Kit by comparing the results obtained using the kit (both by trained operators and lay users) against whole blood samples analyzed on predicate laboratory equipment. This demonstrates the performance of the device (the collection kit) in isolation of further human interpretation (beyond the initial sample collection).

7. Type of Ground Truth Used

The ground truth used was laboratory reference measurements from venous whole blood samples analyzed on established and previously cleared predicate HbA1c testing systems (Roche Cobas Integra, HbA1c Cassette; Roche Cobas Mira, Unimate Reagent; Bio-Rad Diamat Glycosylated Hemoglobin Analyzer System). This represents an objective, quantitative measurement from a standard clinical method.

8. Sample Size for the Training Set

The document does not mention a training set. This is expected because the device is a sample collection kit and not a machine learning model that requires a training phase. The described study is a performance validation study.

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

Not applicable, as there was no training set for this device.

Summary

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K983253

NOV 20 1998

CONFIDENTIAL

Summary of Safety and Effectiveness

Submitted by:	Denise HaleyRegulatory Affairs SpecialistMediSense, Inc.4A Crosby DriveBedford, MA 01730
Device Name:	Precision A1c™ Home HbA1c Sample Collection Kit
Common Name:	Self-monitoring hemoglobin A1c (glycosylated hemoglobin)capillary blood sample collection kit; dried blood spot (DBS) card
Classification:	Glycosylated Hemoglobin Assay(Class II per 21 CFR 864.7470)
Predicate Devices:	EZCHEK™/HbA1c Sample Collection Kit--K971919Self-Assure®/GHb--K861697/AAccu-Chek™ A1c Hemoglobin Test--K974491Roche Cobas® Integra HbA1c--K961824Roche Unimate HbA1c Reagent--K952337/S1Bio-Rad Diamat Glycosylated Hemoglobin Analyzer System--K851636
Description:	The Precision A1c Home HbA1c Sample Collection Kit contains thematerials necessary to collect a capillary blood sample from a finger-stickto a piece of filter paper and mail it to a clinical laboratory for thedetermination of percent hemoglobin A1c (also known asglycohemoglobin or glycosylated hemoglobin).The Precision A1c sample collection kit contains a lancet, patientinformation sheet, instruction sheet, alcohol pad, gauze pad, bandage, pre-paid mailing envelope, and a blood sample collection card (inside a zip-locked foil pouch containing a desiccant).
Intended Use:	The Precision A1c Home HbA1c Sample Collection Kit is intended to be ahome-use or office-use device for the collection of a capillary bloodsample on a blood sample collection card for in vitro diagnostic laboratoryevaluation of the amount of HbA1c (glycosylated hemoglobin). Thiscollection device will be used to monitor long-term blood glucose controlin patients with diabetes mellitus.The Precision A1c sample collection device will be marketed over-the-counter. This kit is not indicated for the diagnosis of diabetes mellitus.

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Comparison to

Predicate Device: The proposed Precision A1c Home HbA1c Sample Collection Kit has components, technological characteristics, and an intended use equivalent to predicate HbA1c collection devices such as the EZCHEK™/HbA1c (K971919), Accu-Chek™ A1c Hemoglobin Test and the Self-Assure®/GHb (K861697/A) Sample Collection Kits. The use of this kit affects only the sample collection stage of the testing process.

The HbA1c results obtained from blood samples collected with the Precision A1c Home HbA1c Sample Collection Kit were equivalent to results obtained from whole blood samples analyzed on the Roche Cobas Integra, HbA1c Cassette (K961824), Roche Cobas Mira, Unimate Reagent (K952337/S1) and Bio-Rad Diamat Glycosylated Hemoglobin Analyzer System (K851636).

Performance Studies:

Performance studies were conducted on blood samples collected with Precision A1c cards by both lay users and trained operators at three sites. A corresponding venous whole blood sample was also collected from each patient in the study as a control sample to compare whole blood results to those obtained from blood samples collected with the Precision A1c card. Samples from two clinical sites were then mailed to LabOne for determination of percent glycohemoglobin. Samples collected by the University of Missouri were not mailed but were tested on-site.

Performance studies included:

-Correlation of %HbA1c values obtained with whole blood vs. samples collected on the Precision A1c card by trained operators. -Correlation of %HbA1c values obtained with whole blood vs. samples collected on the Precision A1c card by lay users. -Correlation of %HbA1c values obtained by trained operators vs. lay users on samples collected with the Precision A1c card.
The performance results from all sites combined are described below:

	Trained Operatorusing the Precision A1cSample Collection Kitvs. Whole Blood	Lay User using thePrecision A1c SampleCollection Kit vs.Whole Blood	Trained Operator vs. LayUser-both using thePrecision A1c SampleCollection Kit
Correlation Coefficient	0.993	0.989	0.996
Slope	1.019	1.016	0.999
y-Intercept	-0.02	-0.05	-0.04
Sy.x	0.22	0.27	0.18
Bias	0.12	0.07	-0.05
Mean Absolute % Bias	2.50	2.77	1.76
N	258	259	259

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CONFIDENTIAL

Conclusion:

Both the correlation coefficients and slopes obtained in this study were close to 1.000 and the y-intercepts close to 0.0. Results indicate excellent correlation between venous whole blood samples and capillary blood samples (collected with the Precision A1c Kit) and analyzed by the Roche Cobas Systems. In addition, equivalent results were achieved by lay users and trained operators when compared against each other.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

NOV 20 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Denise Haley Requaltory Affairs Specialist MediSense, Inc. 4A Crosby Drive Bedford, Massachusetts 01730

Re : K983253

Precision A1c™ Home HbA1c Sample Collection Kit Trade Name: Requlatory Class: II Product Code: LCP Dated: September 15, 1998 Received: September 16, 1998

Dear Ms. Haley:

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 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). 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 Requlations, 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 regulation 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 legally 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 diagnostic 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 regulation 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 Butman

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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INDICATIONS FOR USE FORM

K9832,53 510(k) Number (if known):

Device Name: Precision™ A1c Home HbA1c Sample Collection Kit

Indications For Use:

The Precision Alc sample collection device will be marketed over-the-counter. This kit is not indicated for the diagnosis of diabetes mellitus.

Image /page/5/Picture/7 description: The image shows a black line drawn diagonally across a white background. The line starts in the upper left corner and extends to the lower right corner. The line is slightly curved in the upper left corner and becomes straighter as it extends to the lower right corner. The line appears to be hand-drawn, with slight variations in thickness and texture.

(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.108)	✓
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or
Both

Over-The-Counter Use	✓
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(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number	K983253
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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).