The Precision® and Optium® Point of Care Blood Test Strips quantitatively measure glucose (D-glucose) in fresh neonatal, venous, arterial and fingertip capillary whole blood. The test strips are for use outside the body (in vitro diagnostic use) by healthcare professionals for use in healthcare facilities with either the Precision Xtra® or Optium® Blood Glucose Monitoring Systems. Home users may use the system for capillary samples only. The test strips are not for use in diagnosis or screening of diabetes mellitus, but are to be used as an aid in monitoring the effectiveness of diabetes control programs.

Device Description

The Precision® /Optium® Point of Care Blood Glucose Test Strips work on the principle of amperometric biosensor technology, by determination of glucose oxidised by the enzyme (Glucose Dehydrogenase, GDH) catalysed reaction with Nicotinamide Adenine Dinucleotide (NAD). The reduced form of NAD (NADH) is re-oxidized by reaction with the electrochemical mediator, 1,10 phenanthroline quinone (1,10PQ). The reduced mediator is re-oxidized via electron transfer at the electrode surface. This current is translated into a number by the meter, after applying lot specific information from the supplied ROM calibrator and after a 20 second countdown, a concentration value is presented to the user.

AI/ML Overview

The provided document is a 510(k) summary for the Precision® Point of Care Blood Glucose Test Strip and Optium® Point of Care Blood Glucose Test Strip. It describes the device, its intended use, and substantial equivalence to a predicate device based on non-clinical and clinical performance data.

However, the document does not contain the detailed information required to answer all the questions about specific acceptance criteria and the comprehensive study details. It generally states that "studies demonstrated that the Precision® Point of Care Blood Glucose Test Strips/ Optium® Point of Care Blood Glucose Test Strips are substantially equivalent" and lists some types of tests performed (altitude, dynamic range, precision, linearity, accuracy, interference, oxygen sensitivity, environmental, hematocrit, shipping and shelf life) but does not provide:

A table of specific acceptance criteria values.
Reported device performance against those specific criteria.
Sample sizes for test sets or training sets.
Data provenance for either training or test sets.
Details on expert involvement, ground truth establishment, or adjudication methods for either training or test sets.
Information on MRMC studies or standalone algorithm performance.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided in detail. The document states that the device "passed" various tests like "altitude, dynamic range, precision, linearity, accuracy, interference, oxygen sensitivity, environmental, hematocrit, shipping and shelf life." However, no specific numerical acceptance criteria (e.g., "accuracy within X%") or the exact reported performance values are given. The general conclusion is that the performance is "acceptable and comparable to the performance of the previously mentioned predicate device for blood glucose testing."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not specify the sample sizes used for the clinical or non-clinical testing. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Cannot be determined. For a blood glucose test strip, the "ground truth" is typically established by comparative measurements against a laboratory reference method (e.g., a YSI analyzer), not by human expert consensus or radiologists. The document does not mention the involvement of experts in establishing ground truth, as it's not relevant for this type of device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Cannot be determined. Adjudication methods like 2+1 or 3+1 are typically used in image-based diagnostic studies where human readers interpret results. For a blood glucose test strip, the "reading" is a numerical value, and the comparison is to a reference instrument, not a human interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. MRMC studies and the concept of "human readers improving with AI assistance" are relevant for software-as-a-medical-device (SaMD) or AI-powered diagnostic tools, especially in imaging. This document describes a physical medical device (blood glucose test strips) that provides a direct numerical measurement. There is no AI component or human reader interpretation in the sense of an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable in the usual sense. This is a hardware device (test strip) that works with a monitoring system. Its "performance" is the accuracy and precision of the glucose measurement it provides, which is inherently "standalone" in that it produces a value. There's no separate "algorithm only" performance to speak of outside of the integrated system. The clinical and non-clinical studies verify the performance of the strip used with the meter.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Implied reference method comparison. For a blood glucose test strip, the ground truth for accuracy and precision studies would be established by comparing the device's readings against a highly accurate laboratory reference method (e.g., a YSI glucose analyzer, typically considered the gold standard for glucose measurement in lab settings). While not explicitly stated, this is the standard practice for such devices. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Cannot be provided. The document does not discuss a "training set" in the context of machine learning. The device is based on "amperometric biosensor technology" and does not appear to involve a machine learning model that would require a dedicated training set. It is a chemical-electronic measurement system.

9. How the ground truth for the training set was established

Not applicable, as no training set is discussed.

Summary of what is known:

Device: Precision® / Optium® Point of Care Blood Glucose Test Strips.
Technology: Amperometric biosensor technology, using Glucose Dehydrogenase (GDH) and Nicotinamide Adenine Dinucleotide (NAD) to detect glucose.
Performance verified by: Non-clinical (laboratory) and clinical testing.
Tests performed (general categories): Altitude, dynamic range, precision, linearity, accuracy, interference, oxygen sensitivity, environmental, hematocrit, shipping, and shelf life.
Conclusion: The device is substantially equivalent to the predicate device (K021960) and suitable for its intended use.
Ground Truth (inferred): Likely established by comparison to a laboratory reference method for glucose measurement.

Summary

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K070984

Image /page/0/Picture/1 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized letter "A" on the left, followed by the words "Abbott" and "Diabetes Care" stacked on top of each other on the right. The text is in a bold, sans-serif font.

Abbott Diabetes Care Inc. 1360 South I oop Road Alameda, CA 94502 t: (510) 749-5400

NOV - 1 2007

510(k) Summary

(as required by 21 CFR 807.92)

Date Prepared:	October 09, 2007
Company	Abbott Laboratories
Division	Abbott Diabetes Care Inc.
Street Address	1360 South Loop Road
City, State Zip	Alameda, CA 94502
Telephone No.	510-749-5400
Fax No.	510-864-4791
Contact Person:	Maria TrejoRegulatory Affairs AssociateTel No. 510-749-6384Fax No. 510-864-4791maria.trejo@abbott.com
Device Name:	Precision® Point of Care Blood Glucose Test StripOptium® Point of Care Blood Glucose Test Strip
Common Name:	Blood Glucose Test Strip
Classification Name:	Glucose Dehydrogenase, Glucose. Glucose Test System,Class II (21 CFR §862.1345, Product code LFR)
Predicate Device:	Precision®/ Optium® Point of Care Blood Glucose TestStrips (K021960)

Description of the Device:

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Image /page/1/Picture/0 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized letter "a" on the left, followed by the words "Abbott" and "Diabetes Care" stacked on top of each other on the right. The text is in a bold, sans-serif font.

Intended Use:

The Precision®/Optium® Point of Care Blood Glucose Test Strips quantitatively measure I he I receision > Operain > > Sprain > > arterial and fingertip capillary whole blood. The test strips are for use outside the body (in vitro diagnostic use) by healthcare I no cost surpo are in healthcare facilities with either the Precision Xtra® or Optium® Blood Glucose Monitoring Systems. Home users may use the system for capillary samples only. The test strips are not for use in diagnosis or screening of diabetes mellitus, but are to be used as an aid in monitoring the effectiveness of diabetes control programs.

Summary of Technological Characteristics:

The Precision® Point of Care Blood Glucose Test Strips/ Optium® Point of Care Blood Glucose Test Strips have the same fundamental scientific technology and the same intended use as the current Precision® Point of Care Blood Glucose Test Strips and Optium® Point of Care Blood Glucose Test Strips which is based on amperometric biosensor technology. The Precision® Point of Care Blood Glucose Test Strips/ Optium® Point of Care Blood Glucose Test Strips are substantially equivalent to the current predicate device.

Assessment of Non-Clinical Performance Data:

The performance of the Precision®/Optium® Point of Care Blood Glucose Test Strips was verified through non clinical testing in the laboratory. These studies demonstrated that the Precision® Point of Care Blood Glucose Test Strips/ Optium® Point of Care Blood Glucose Test Strips are substantially equivalent to the current Precision® Point of Care Blood Glucose Test Strips/Optium® Point of Care Blood Glucose Test Strips for blood glucose measurements and are suitable for its intended use.

Assessment of Clinical Performance Data:

The performance of the Precision®/Optium® Point of Care Blood Glucose Test Strips was also verified through clinical testing. Some of the test performed and passed were altitude, dynamic range, precision , linearity, accuracy, interference, oxygen sensitivity, environmental, hematocrit, shipping and shelf life. These studies demonstrated that the Precision® Point of Care Blood Glucose Test Strips/ Optium® Point of Care Blood Glucose Test Strips are substantially equivalent to the current Precision® Point of Care Blood Glucose Test Strips/Optium® Point of Care Blood Glucose Test Strips for blood glucose measurements and are suitable for its intended use.

Conclusion:

Results of clinical and non-clinical testing demonstrate that the performance of the Precision® Point of Care Blood Glucose Test Strips and Optium® Point of Care Blood Glucose Test Strips, when used according to the intended use stated above, are acceptable and comparable to the performance of the previously mentioned predicate device for blood glucose testing.

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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 & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Abbott Laboratories Abbott Diabetes Care Inc. c/o Ms. Maria Trejo Regulatory Affairs Associate 1360 South Loop Road Alameda, CA 94502

NOV - 1 2007

Re: K070984

Trade/Device Name: Precision® Point of Care Blood Glucose Test Strips Optium® Point of Care Blood Glucose Test Strips Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Code: LFR, NBW Dated: October 10, 2007 Received: October 15, 2007

Dear Ms. Trejo:

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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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 (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K070984

Device Name: Precision® Point of Care Blood Glucose Test Strips Optium® Point of Care Blood Glucose Test Strips

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Ben

Page 1 of 1

ion Sign-Off

ിfice of In Vitro Diagnostic Device I Valuation and Safety

K070984j

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.