For over-the-counter at home or doctor's office use to obtain a finger stick whole blood sample for laboratory to monitor long-term (4-8 weeks) blood sugar control in individuals with diabetes mellitus. Not indicated for diagnosis of diabetes mellitus.

Device Description

The device is a kit containing the materials required to collect a capillary blood sample from a finger-stick on a piece of filter paper and mail it to a laboratory for determination of its hemoglobin A16 %. The kit contains a lancet, an alcohol wipe, a test request form with filter paper, a biohazard bag, a return envelope with lifter papereturning a result to the patient and/or his/her doctor.

AI/ML Overview

Here's an analysis of the provided text regarding the EZCHEK™/HbA1c Sample Collection Kit's acceptance criteria and studies:

Acceptance Criteria and Device Performance

The acceptance criteria are implied through correlation coefficients and precision values. The studies demonstrated that the device (specifically, the collection method on filter paper combined with the new antibody-based analytical method) correlates well with existing whole blood hemolysate tests and exhibits acceptable precision.

Metric	Acceptance Criteria (Implied)	Reported Device Performance (Nonclinical)	Reported Device Performance (Clinical - Office)	Reported Device Performance (Clinical - Home)
Correlation (r)	High (e.g., >0.95)	0.988	0.978	0.956
Equation (y=mx+c)	Close to y=x	y = 1.03x - 0.13	Y = 0.999x + 0.06	y = 0.983x + 0.37
Within-run Precision	Not explicitly stated	2.9% at 6.7% HbA1c	Not reported	Not reported
Total Precision	Not explicitly stated	3.3% at 6.7% HbA1c	Not reported	Not reported
Stability (temperature)	Compatible with transport	Shown to be compatible	Not reported	Not reported
Stability (freeze-thaw)	Compatible with transport	Shown to be compatible	Not reported	Not reported
Ease of Use (User Feedback)	Acceptable	Not reported	Acceptable (indicated by questionnaires)	Acceptable (indicated by questionnaires)

Study Details

Sample Sizes and Data Provenance:
- Nonclinical Performance Data (Correlation): n = 53 (data provenance not specified, but this would likely be laboratory-based testing)
- Clinical Performance Data (Office Use): n = 56 (data provenance not specified, but implied to be from three clinical sites)
- Clinical Performance Data (Home Use): n = 43 (data provenance not specified, but implied to be from patients collecting samples at home)
- Retrospective/Prospective: Not explicitly stated, but the "clinical performance data" sounds prospective given the evaluation of kits in sites and patient questionnaires. The "nonclinical performance data" could be either.
Number of Experts and Qualifications for Test Set Ground Truth:
- The document does not mention the number of experts or their qualifications for establishing the ground truth for the test set. The ground truth refers to "whole blood hemolysate tests," which are a reference method, not expert-derived.
Adjudication Method for the Test Set:
- This is not applicable as the studies primarily involve correlation comparisons against a reference laboratory method (whole blood hemolysate tests), not subjective expert judgment requiring adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. This type of study is typically used for imaging or diagnostic tools where human readers interpret results, and the AI's impact on their performance is evaluated. The EZCHEK™ kit is a sample collection device for a laboratory test, not an interpretive tool for human readers.
Standalone (Algorithm Only) Performance:
- Yes, the performance presented for the device is essentially standalone. The "device" here is the collection kit, and its performance is evaluated in terms of how well the collected sample yields results that correlate with a reference method. The "new antibody based method" which processes the collected samples is itself FDA cleared and operates in a standalone manner.
Type of Ground Truth Used:
- The ground truth used was "whole blood hemolysate tests." This is a laboratory reference method for HbA1c determination, considered the gold standard for comparison in these studies.
Sample Size for the Training Set:
- The document does not provide information about a "training set" or its size. This is because the device described is a sample collection kit and the new analytical method it uses is already FDA cleared. The studies presented are validation studies of the combined system (collection method + new analytical method), not a new AI algorithm that requires training.
How Ground Truth for the Training Set Was Established:
- Not applicable, as no training set for an AI algorithm is mentioned or implied.

Summary

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K971919

58 9-5-97

Image /page/0/Picture/2 description: The image shows the text "FLEXSITE DIAGNOSTICS, INC." in a bold, serif font. The word "FLEXSITE" is followed by a stylized globe-like image with horizontal lines. The text is slightly angled upwards from left to right. The overall impression is that of a professional logo or company name.

510(K) SUMMARY

May 21, 1997

SUBMITTER:	FLEXSITE DIAGNOSTICS, INC.3543 SW CORPORATE PARKWAYPALM CITY, FL 34990
	PHONE: 561 221-8893FAX: 561 221-9671
CONTACT PERSON:	Robert RayFLEXSITE DIAGNOSTICS, INC.PHONE: 561 221-8893FAX: 561 221-9671
TRADE NAME:	EZCHEK™/HbA1c Sample Collection Kit
COMMON NAME:	Self-monitoring glycohemoglobin (hemog

globin Aic Self-monitoring glycohemog. COMMON NAME: capillary blood collection kit.

Glycosylated Hemoglobin Assay CLASSSIFICATION NAME: (21C.F.R. 864.7470)

Self-Assure®/GHb; K861697/A. PREDICATE DEVICE:

The device is a kit containing the materials required to DESCRIPTION: The do no no a capillary blood sample from a finger-stick on a piece of filter paper and mail it to a laboratory for determination of its hemoglobin A16 %. The kit contains a lancet, an alcohol wipe, a test request form with filter paper, a biohazard bag, a return envelope with lifter papereturning a result to the patient and/or his/her doctor.

43 245

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INTENDED USE: The device is intended for at-home or in-office use to collect a sample for hemoglobin A1c determination. The product will be marketed over-the-counter.

SUMMARY OF TECHNOLOGICAL SIMILARITIES AND DIFFERENCES:

The key components of the kit are functionally identical to SIMILARITIES: those in the Self-Assure kit.

DIFFERENCES: 1. The method of analysis of glycohemoglobin has changed from attinity chromatography to an antibody method from another commercial source. This method is FDA cleared.

1. The filter paper treatment has been changed to be compatible with the new antibody method. The new treatment is with a standard chemical in common use in clinical labs.
1. The name of the product has been changed.

NONCLINICAL PERFORMANCE DATA: The principal difference as noted in labove is the method of analysis. The new antibody based method, which as cleared uses whole blood or whole blood hemolysate samples, was shown to give accurate results when using blood spots collected on filter paper as judged from the following correlation data: y = 1.03x -0.13; r = 0.988; n = 53. The precision of measuring blood spots was 2.9% within run at 6.7% HbAt. Total precision over a 20 day study was 3.3 % at 6.7% HbAis. The stability of blood spots at temperature extremes was shown to be compatible with expected transport conditions (up to 115°F and to three freeze-thaw cycles).

CLINICAL PERFORMANCE DATA: Kits were evaluated in three sites to confirm the ease of use by medical professionals in an office setting. Results were also correlated to whole blood hemolysate tests as an additional confirmation of the validity of collection on filter paper. Correlation was Y =0.999x + 0.06; r = 0.978; n = 56. Patients given the kit to take home gathered samples and mailed them to the laboratory. These results also correlated very well (y = 0.983x +0.37; r = 0.956; n= 43) to whole blood hemolysate results. Patients filled out questionnaires regarding the ease of use etc. Their comments indicated that the kit is acceptable as designed.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP - 5 1997

Donald R. Stone Flexsite Diagnostics, Tnc. C/O McKenna & Cuneo, L. L. P. 1900 K Street, N.W. -Washington, D.C. 20006-1108

K971919 Re : EZCHEK™/HBA Sample Collection Kit Regulatory Class: II Product Code: LCP August 15, 1997 Dated: Received: August 15, 1997

Dear Mr. Stone:

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 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 The general controls provisions of provisions of the Act. 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 Good Manufacturing Practice for Medical Devices: General (CMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the CMP regulation may result in regulatory action. in addition, FDA may publish further announcements concerning Please note: this your device in the Federal Register. 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (CHIA-66), Child device may if it does, you should contact categorization: - 16 accessions on Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your 510(k) picmailor of your device to a legally marketed predicate device results in a classification for your marketed predicate device formits your device to proceed to the market.

If you desire specific advice for your device on our labeling II you debire bpcorrart 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Additionally, for questions on Compliance at (301) 594-4588. Compriance ac (30 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 obtained from the brying (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Hutman

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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510(k) Number: K971919

5 IO(P) Number. Its ve

Indications for Use: ..

Indications for Use:

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s a lot any to tooting to monitor long-term (4-8 weeks) For over-the-counter at bome or doctor's office use to obtain a more success of the second on the second on the second of the second of the security in disable for the For over-the-counter at boze of the ever of 4-8 weeks) blood sugar control in unocellar - con
for laboratory to monitor long-term (4-3 weeks) blood sugar on not indicated for results should of diabetes mellitus.
diagnosis of diabetes mellitus.

(Division ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Division of Chine I Laoura 510(k) Number -

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-The-Counter Use

Prescription Use (Per 21 CFR 801.109) OR

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).