ATLAST GLUCOSE CONTROL SOLUTION

K991075 · Amira Medical, Inc. · JJX · May 10, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991075
• Device Name: ATLAST GLUCOSE CONTROL SOLUTION
• Applicant: Amira Medical, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

For use with the AtLast Blood Glucose System for quality control purposes to verify that the AtLast meter and test strips perform well together.

Device Story

AtLast Glucose Control Solution is an aqueous control used for quality control of the AtLast Blood Glucose System. The system is an OTC combination blood sampler and glucose meter for diabetic consumers. Operation involves the user breaking off the cap of the control packet, placing a drop on a surface, and touching the AtLast test strip to the solution. The meter draws the fluid via capillary action, performs a glucose assay, and displays the result in mg/dL on a digital readout. This allows users to verify that the meter and test strips are functioning correctly, ensuring accurate blood glucose measurements from various body sites.

Clinical Evidence

Bench testing only. Precision studies were conducted using three AtLast systems, in triplicate, over 20 days, resulting in 60 measurements per level per meter. Data were analyzed per NCCLS Document EP 5-T2 to determine within-run and total imprecision. Results indicated good performance for all glucose levels.

Technological Characteristics

Aqueous glucose control solution. Principle of operation relies on capillary action to draw the solution into the AtLast test strip for electrochemical glucose assay. Designed for use with the AtLast Blood Glucose System. No specific materials of construction or software algorithms are described for the control solution itself; it is a chemical reagent.

Indications for Use

Indicated for use by diabetic consumers as an assayed control solution to verify the performance of the AtLast Blood Glucose System (meter and test strips).

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Accu-Chek® Instant™ (K944459) Glucose Control

Reference Devices

• AtLast Blood Glucose System (K982076)

Submission Summary (Full Text)

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#### B. 510(k) SUMMARY

## Amira Medical 510(k) Premarket Notification for The AtLast™ Control Solution

## 1. Submitter's Name, Address, Telephone Number, and Contact Person

Amira Medical 4742 Scotts Valley Road Scotts Valley, CA 95066 Phone:[phone] Facsimile: [phone]

> Contact Person: Nina Peled, Ph.D., MBA Vice President, Scientific Affairs

## 2. Date Prepared: March 25, 1999

## 3. Name of Device and Name/Address of Sponsor

Trade name: The AtLast™ Control Solution

Amira Medical 4742 Scotts Valley Road Scotts Valley, CA 95066

## 4. Classification Names:

Single (specified) analyte controls (assayed and unassayed) (21 C.F.R. § 862.1660)

#### 5. Predicate Devices

The Accu-Chek® Instant™ (K944459) Glucose Control (Accu-Chek, Roche Diagnostics, Indianapolis, IN.)

## 6. Intended Use/Indications

For use with the AtLast Blood Glucose System for quality control purposes to verify that the AtLast meter and test strips perform well together.

## 7. Device Description

The AtLast Glucose Control Solution is an aqueous control. The control is intended to be used with the Atl.ast Blood Glucose System (AtLast System, K982076) for quality control purposes by the end-user (diabetic consumer). The AtLast System is an over-the-counter

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(OTC) combination blood sampler and glucose meter that provides blood glucose measurements on samples obtained from various body sites including the forearm, the upper arm, the thigh and the finger tip.

# 8. Principle of Operation

The AtLast control solutions are utilized as follows. Users are instructed to tilt the cap of the control packet until it breaks off. A drop of the control solution is then placed on a clean surface. The AtLast test strip is inserted into the AtLast meter in turned on. The tip of the AtLast test strip is then touched to the control solution to draw up the fluid into the AtLast test strip by capillary action and the meter performs the glucose assay. Results are displayed by digital readout of glucose in mg/dL just as would be done with the user's blood sample.

## 9. Data Demonstrating Substantial Equivalence

The AtLast Glucose Control solutions were evaluated via comprehensive precision studies. Each level of glucose control was assayed with three AtLast systems, in triplicate, over 20 days. This resulted in a total of 60 measurements per level, per meter. The data were analyzed according to NCCLS Document EP 5-T2. "Evaluation of Precision Performance of Clinical Chemistry Devices," 2™ Edition, Vol. 12, No. 4, and are expressed in terms of: within-run imprecision, and total imprecision.

The data indicate qood performance for all qlucose levels.

## Conclusion:

The Studies demonstrate that the Amira Medical AtLast Control Solution is safe and effective for its intended use.

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MAR 17 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Nina Peled, Ph.D., MBA Vice President, Scientific Affairs Amira Medical 4742 Scotts Valley Road Scotts Valley California 95066

Re: K991075 Trade Name: The AtLast™ Control Solution Regulatory Class: I Product Code: JJX Dated: March 30, 1999 Received: March 31, 1999

Dear Dr. Peled:

This letter corrects our substantially equivalent letter dated May 10, 1999 to change from prescription use to over-the-couter-use. 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 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 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] 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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#### 8314390970 91704/1995 20:13

AMIRA MEDICAL

Page 1 of 1

Kaarozz (IF KNOWS) : 510 (k) NUMBER

ATLAST GLUCOSE CONTROL SOLUTION DEVICE NAME:

INDICATIONS FOR USE:

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t and any ality gentrol purposes to verify that the AtLast An assayed control solution for use with the AcLass.
System for quality control purposes to verify that the AtLast
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meter and test strips perform well together.

Peter E. Machi

(Division Sign-Off)
Division of Clinical Laboratory Devices K991015
510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

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