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 (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.

AI/ML Overview

This document describes the AtLast™ Control Solution, an aqueous glucose control solution intended for use with the AtLast Blood Glucose System for quality control purposes.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria for the AtLast™ Control Solution. It only describes the study conducted and the conclusion drawn from it.

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Presumably, sufficient precision across glucose levels to ensure accurate quality control and functionality of the AtLast Blood Glucose System.	"The data indicate good performance for all glucose levels." (Based on precision studies)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Each level of glucose control was assayed:
- with three AtLast systems.
- in triplicate (3 measurements per system per level per day).
- over 20 days.
- This resulted in a total of 60 measurements per level, per meter (3 systems * 3 measurements/day/system * 20 days = 180 total measurements per level across the three systems, or 60 measurements per level for each individual meter).
Data Provenance: The document does not specify the country of origin of the data. It is a prospective study as it describes a specific experimental setup to generate data for evaluation.

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

This section is not applicable as the device is a control solution for a glucose meter. Ground truth in this context would likely refer to the verified concentration of glucose in the control solution itself, which is inherently part of its manufacturing specification, rather than requiring expert interpretation of diagnostic images or clinical cases. The "ground truth" for the performance evaluation would be the expected glucose concentration of the control solution against which the meter readings were compared for precision.

4. Adjudication Method for the Test Set

This section is not applicable. As a control solution, there is no "adjudication" in the sense of reconciling differing expert opinions or classifications. The evaluation focuses on statistical precision and accuracy against a known target value.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images. The AtLast™ Control Solution is an in-vitro diagnostic control.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The study described evaluates the performance of the AtLast Glucose Control solutions in conjunction with the AtLast Blood Glucose System. While the blood glucose meter itself has an "algorithm" to measure glucose, the study's focus is on the control solution's ability to demonstrate consistent results when used with the meter and test strips. It is not an evaluation of an artificial intelligence algorithm in a standalone capacity.

7. The Type of Ground Truth Used

The ground truth for evaluating the control solution's performance would be the assigned target value (known glucose concentration) of each level of the control solution. The study focused on the precision of the measurements obtained using the control solution with the AtLast system, which implicitly relies on the control having a known and stable glucose concentration.

8. The Sample Size for the Training Set

This section is not applicable. The AtLast™ Control Solution is a diagnostic control, not an AI/ML algorithm that requires a training set. The "data" mentioned in the document refers to performance evaluation data generated through laboratory testing, not data used to train a model.

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

This section is not applicable for the same reasons as point 8.

Summary

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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:(408) 440 5448 Facsimile: (408) 439-0907

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

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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 (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" (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 (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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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:

an assayed control solution for use with the Atlast Blood Glucose
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
. System for quality concror perform well together.
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)

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.