A1CNOW FOR HOME USE

K022661 · Metrika, Inc. · LCP · Dec 13, 2002 · Hematology

Device Facts

• Record ID: K022661
• Device Name: A1CNOW FOR HOME USE
• Applicant: Metrika, Inc.
• Product Code: LCP · Hematology
• Decision Date: Dec 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

The A1cNow™ test provides quantitative measurement of the percent of glycated hemoglobin (% HbA1c) levels in fingerstick (capillary) whole blood samples. The test is for home use by people with diabetes to monitor glycemic control.

Device Story

A1cNow™ for Home Use is a single-use, self-contained, four-channel reflectance photometer for home monitoring of glycemic control. Device requires no switches or buttons; self-activates upon application of diluted fingerstick whole blood to sample port. Internal mechanism utilizes immunoassay and chemistry technology: blue microparticles conjugated to anti-HbA1c antibody migrate along reagent strips to measure HbA1c; total hemoglobin measured via conversion to red-brown met-Hb. Reflectance photometer quantifies color intensity on strips. Results displayed on LCD after eight minutes. Device provides patients with quantitative HbA1c data to assist in diabetes management. Factory calibrated; no end-user calibration required.

Clinical Evidence

Clinical study conducted with approximately 300 untrained subjects. Results demonstrated 98% accuracy compared to standard laboratory methods. Average estimated bias between consumer results and laboratory reference was less than 2%. Nonclinical data confirmed linearity between 3% and 13% HbA1c, hematocrit tolerance between 20% and 60% PCV, and precision of approximately 5.4 %CV.

Technological Characteristics

Four-channel reflectance photometer; integrated single-use device. Incorporates microelectronics, optics, and dry-reagent chemistry strips. Methodology: Immunoassay for HbA1c; chemistry for total hemoglobin. Factory calibrated. LCD readout. No switches or buttons. Operates on whole blood samples.

Indications for Use

Indicated for people with diabetes to monitor long-term glycemic control via quantitative measurement of %HbA1c in capillary whole blood samples.

Regulatory Classification

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.

Predicate Devices

• A1cNow™ for Rx Home Use (K020234)

Reference Devices

• A1cNow™ for Rx Home Use (K000885)

Submission Summary (Full Text)

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## M = T R I K A

## DEC 1 3 2002

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is K022661

| 807.92 (a)(1): Name: | Metrika, Inc. |
|----------------------|----------------------|
| Address: | 510 Oakmead Parkway |
| | Sunnyvale, CA 94085 |
| Phone: | [phone] |
| FAX: | [phone] |
| Contact: | Joel M. Blatt, Ph.D. |

#### 807.92 (a)(2): Device name- trade name and common name, and classification

Trade name: A1cNow™ for Home Use

Common Name: percent hemoglobin A1c (percent glycosylated hemoglobin)

Classification: assay, glycosylated hemoglobin 21 CFR 864.7470

#### 807.92 (a)(3): Identification of the legally marketed predicate device

A1cNow™ for Home Use is substantially equivalent to A1cNow™ for Rx Home Use (K020234). The only difference between the two tests is in the intended use; A 1 Now TM for Home Use will be marketed directly to the diabetic consumer, while AlcNow™ for Rx Home Use requires a prescription. The device and procedural steps are identical.

#### 807.92 (a)(4): Device Description

AlcNow™ for Home Use is a four-channel reflectance photometer that incorporates microelectronics, optics, and dry-reagent chemistry strips within a self-contained, integrated, single-use device. An unmeasured whole blood mixture (diluted) is applied directly to the sample port, and results are displayed in numeric form on the device's liquid crystal display after eight minutes. Having no switches or buttons, the device self-activates upon addition of the sample.

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#### 807.92 (a)(4): Device Description (continued)

A1cNow™ for Home Use utilizes both immunoassay and chemistry technology to measure HbA1c and total hemoglobin, respectively. Upon the addition of a diluted blood sample, blue microparticles conjugated to anti-HbA1c antibody migrate along the reagent strips. The amount of blue microparticles captured on the strips reflects the amount of HbA1c in the sample.

For the total hemoglobin portion of the assay, the dilution of sample converts Hb to met-Hb, which is red-brown in color. The intensity of the red-brown color measured on the reagent strips is proportional to the concentration of hemoglobin in the sample.

#### 807.92 (a)(5): Intended use

The A1cNow™ test provides quantitative measurement of the percent of glycated hemoglobin (% HbA1c) levels in fingerstick (capillary) whole blood samples. The test is for home use by people with diabetes to monitor glycemic control.

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| CHARACTERISTIC | A1cNow™ for Home Use | A1cNow™ for Rx Home Use<br>K020234, K000885 |
|------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative measurement of the<br>percent of glycated hemoglobin | Quantitative measurement of the<br>percent of glycated hemoglobin |
| Indications for Use | Used in the management and<br>treatment of diabetes, for<br>monitoring long term glycemic<br>control | Used in the management and<br>treatment of diabetes, for<br>monitoring long term glycemic<br>control |
| Risk to Patient | Not a critical analyte - reflects<br>glucose monitoring over time | Not a critical analyte - reflects<br>glucose monitoring over time |
| Sample | Whole blood | Whole blood |
| Visual Display | LCD readout | LCD readout |
| Hemolysate Preparation | Manual (Sample Dilution Kit) | Manual (Sample Dilution Kit) |
| Calibration | Not required by end-user; each<br>unit is factory calibrated | Not required by end-user; each<br>unit is factory calibrated |
| Methodology | Immunoassay | Immunoassay |
| Detection Method | Four-channel reflectance<br>photometer | Four-channel reflectance<br>photometer |
| Testing Environment | Home Use | Rx Home Use |
| Throughput | 8 minutes per sample | 8 minutes per sample |
| Precision | Percent coefficient of variation:<br>approximately 5.4 %CV | Percent coefficient of variation:<br>approximately 6.4 %CV |
| Accuracy (estimated<br>bias) | Biases of 1-2% (±0.1 %A1C)<br>across the range of 6 %A1C to 8<br>%A1C | Biases of 2-3% across the range<br>of 6% A1C to 8 %A1C |
| Accuracy (total error) | Bias plot reveals 95% confidence<br>limits of -0.9 % HbA1c to +1.1<br>%HbAlc | Bias plot reveals 95% confidence<br>limits of -0.8 %HbA1c to +1.2<br>%HbAlc |
| NGSP Certification<br>Status | A1cNow™ NGSP-certified as of<br>June 1, 2002 | Previous submissions predated<br>NGSP certification |

| | Comparisons Between A1cNow™ for Home Use and A1cNowTM for Rx Home Use | | | | | | |
|--|-----------------------------------------------------------------------|--|--|--|--|--|--|
| | | | | | | | |

The differences in the two testing platforms do not raise new issues of safety and effectiveness.

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#### 807.92 (b)(1): Brief Description of Nonclinical Data

Studies were performed that evaluated linearity, hematocrit tolerance, precision, and specificity. Results from these studies were presented in a previous submission, and were not repeated for this submission.

A1cNow™ is linear between 3% and 13% HbA1c. The test produces suitable results with sample hematocrits between 20% and 60% PCV (packed cell volume). The test's imprecision is approximately 5.4 %CV, and the assay is not affected by high levels of various biological compounds, various common overthe-counter therapeutics, and oral antihyperglycemic agents.

#### 807.92 (b)(2): Brief Description of Clinical Data

In clinical studies with approximately 300 untrained subjects, A1cNow™ was 98% accurate. The average estimated bias between the consumer's results and results obtained by a standard laboratory method was less than 2%.

#### 807.92 (b)(3): Conclusions from Nonclinical and Clinical Testing

A 1 c NowTM was evaluated for nonclinical and clinical performance characteristics in comprehensive studies. These studies demonstrated that the test is safe and effective for its intended use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the logo is a stylized image of three faces in profile, one behind the other. The faces are rendered in a simple, flowing line.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Erika Ammirati, R.A.C., MT (ASCP) Clinical/Regulatory Consultant to Metrika Metrika, Inc. - -510 Oakmead Parkway Sunnyvale, CA 94086

Re: k022661

> Trade/Device Name: Metrika A1cNow® for Home Use Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP Dated: October 17, 2002 Received: October 18, 2002

Dear Ms. Ammirati:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Metrika, Inc. IcNow™ Home Use emarket Notification

# STATEMENT OF INTEN

510(K) Number (if known

Device Name: A1cNow™

### Indications for Use:

The AlcNow™ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c) levels in capillary (fingerstick) whole blood samples. The test is for home use by people with diabetes to monitor glycemic control.

Souphine Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices K122661

510k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) ÖR

Over –the-Counter Use