AgaMatrix JAZZ™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/or forearm. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

AgaMatrix JAZZ™ Blood Glucose Meter is intended for use with AgaMatrix JAZZ™ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/or forearm. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

AgaMatrix JAZZ™ Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ™ Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

AgaMatrix JAZZ™ Control Solutions are intended for use with the AgaMatrix JAZZ™ Meter and AgaMatrix JAZZ™ Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Description

The AgaMatrix WaveSense JAZZ™ Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, Lancing device, lancets, control solution and owner's booklet. Test Strips are sold separately. It is intended for over-the-counter home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.

AI/ML Overview

The provided text is a 510(k) Summary for the AgaMatrix WaveSense JAZZ™ Blood Glucose Monitoring System, dated August 17, 2007. It states the device's intended use and that it complies with ISO 15197:2003, but it does not contain information about specific acceptance criteria or a study proving the device directly meets acceptance criteria for accuracy with detailed performance metrics.

The document discusses the device's modification (no coding required), intended use, and compliance with various international standards, including ISO 15197:2003 ("In vitro diagnostic test systems- Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus"). While compliance with ISO 15197 generally implies meeting certain accuracy standards, the specific performance data (e.g., mean absolute relative difference (MARD), percentages within certain error grids) are not present in this summary.

Therefore, I cannot fulfill all parts of your request based solely on the provided text.

Here's what I can provide based on the given information, along with explanations for the missing elements:

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

Acceptance Criteria: The document states compliance with ISO 15197:2003. This standard sets performance requirements for blood glucose monitoring systems.
- ISO 15197:2003 Acceptance Criteria (generally, not explicitly stated in the document, but implied by compliance):
  - For glucose concentrations < 75 mg/dL (4.2 mmol/L), ≥ 95% of results shall fall within ±15 mg/dL (±0.83 mmol/L) of the reference method.
  - For glucose concentrations ≥ 75 mg/dL (4.2 mmol/L), ≥ 95% of results shall fall within ±20% of the reference method.
Reported Device Performance: The provided text does not include specific performance data (e.g., study results, MARD, percentages meeting ISO criteria). It only states, "The system performs as intended and raises no new safety of effectiveness issues." This is a general conclusion, not a data-driven performance report.

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

Sample Size for Test Set: Not specified in the provided text.
Data Provenance (country of origin, retrospective/prospective): Not specified in the provided text.

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)

Ground Truth Establishment for Test Set: This information is not provided. For blood glucose monitoring systems, ground truth is typically established using a highly accurate laboratory reference method (e.g., YSI analyzer), rather than expert consensus.

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

Adjudication Method: Not applicable or not specified. For blood glucose meters, the "ground truth" is determined by a lab reference method, not by expert adjudication of interpretations.

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

MRMC Study: Not applicable. This device is a blood glucose meter, not an AI-assisted diagnostic imaging device that involves human "readers."

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

Standalone Performance: For a blood glucose meter, the "standalone" performance refers to the device's accuracy when measuring blood glucose. While the document implies this was evaluated to meet ISO 15197, the specific results of such a study are not reported in this summary.

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

Type of Ground Truth: Implied to be a laboratory reference method for blood glucose measurement (e.g., YSI glucose analyzer), as is standard for blood glucose meter validation. However, this is not explicitly stated in the provided text.

8. The sample size for the training set

Sample Size for Training Set: Not applicable or not specified. Traditional blood glucose meters are not typically "trained" in the same way machine learning algorithms are. Their performance is based on the underlying electrochemistry and hardware design, and then validated through testing.

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

Ground Truth for Training Set: Not applicable. (See #8).

Summary

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10 Manor Parkway Salem, NH 03079 Office: +1 (603) 328-6000 Fax: =1 (603) 893-4191

JAZZ™ 510 (k) SUMMARY

KN12412

SEP 2 7 2007

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.

1. Submitter's Name, Address, Telephone Number, Contact Person, and date the summary was prepared.

Submitter's Name:	Connie HertelAgaMatrix, Inc.10 Manor ParkwaySalem, NH 03079
Contact Person:	Connie HertelDirector Quality & Regulatory Affairs
Telephone:	(603) 328-6051
Fax:	(603) 893-4191

Date the summary prepared:

August 17, 2007

2. Device Name

Trade/Propritary Name:	WaveSense JAZZ™ Blood Glucose Monitoring System
Common/Usual Name:	Blood Glucose Monitoring System
Classification Name:	Glucose test system (per 21 CFR 862.1345)
Class:	II
Panel:	Chemistry

3. Modification Device:

The modification of WaveSense JAZZ™ blood glucose system does not require the user to enter a calibration code.

Therefore, the device is will be marketed as a NO CODING REQUIRED Blood Glucose Monitoring System.

Description of the Device: 4.

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10 Manor Parkway Salem, NH 03079 Office: +1 (603) 328-6000 Fax: +1 (603) 893-4191

510(k) Summary (Continued)

It is intended for over-the-counter home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.

5. Intended use of the device:

The WaveSense JAZZ 100 Blood Glucose Monitoring System in intended to quantitatively measure blood glucose levels, also known as blood sugar, from fresh capillary whole blood samples taken from the fingertips, palm, or forearem. The WaveSense JAZZ TM Test Strips are for in vitro diagnostic (outside of the body) use only. The WaveSense JAZZ TM System is not for intended for use with neonates.

Testing:

The manufacturer of the WaveSense JAZZ TM Blood Glucose Monitoring System certifies that the device complies with the following:

ISO 15197:2003 In vitro diagnostic test systems- Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus.

ISO 14971:2000 Medical devices - Application of risk management to Medical devices

IEC 61010-1 Medical electrical equipment - General requirement for safety

I EC 61010-2 Safety requirement for electrical equipment for measurement, control and laboratory use -- particular requirements for in vitro diagnostic (IVD) medical equipment

IEC 61000-403 Electromagnetic compatibility (EMC)

6. Conclusions

Based upon the testing and comparison to the predicate device, the WaveSense JAZZ™ Blood Glucose Monitoring System which does not require coding, has the same intended uses, with similar technological characteristics as the predicate device. The system performs as intended and raises no new safety of effectiveness issues.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AgaMatrix, Inc. c/o Connie Hertel Director Quality & Regulatory Affairs 10 Manor Parkway Salem. NH 03079

SEP 2 7 2007

Re: K072413

Trade/Device Name: AgaMatrix JAZZ™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: August 27, 2007 Received: August 28, 2007

Dear Ms. Hertel:

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 logally 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.

Yean 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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Indication for Use

510(k) Number (if known): Kb72.413 Device Name: JAZZ™M Indication For Use:

AgaMatrix JAZZTM Blood Glucose Monitoring System:

AgaMatrix JAZZ™ Blood Glucose Meter:

AgaMatrix JAZZ™ Blood Glucose Test Strips:

AgaMatrix JAZZTM Control Solutions (Normal level and High level):

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

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

Concurrence of CRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Caro Seman

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072413

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.