The Glucose Hexokinase reagent set is intended to be used in a diagnostic laboratory setting by qualified laboratory technologists for the quantitative determination of glucose in human serum and plasma on the Pointe 360 Analyzer. It is for In Vitro diagnostic use only. The determination of glucose in serum and plasma is for use in the diagnosis and treatment of diabetes mellitus.

Device Description

The Pointe 360 is a computerized bench top laboratory instrument. It is capable of automating all stages of assay processing that involve incubation, reagent delivery, mixing, optical reading, calculating, data storage and reporting within specified limits. The glucose reagent set for the Pointe 360 is an assay for the determination of glucose in plasma or serum.

AI/ML Overview

The provided 510(k) summary focuses on demonstrating substantial equivalence of the "Pointe 360 Glucose Hexokinase Reagent Set" to a predicate device, the "Roche Diagnostics Glucose/HK on the Hitachi 917". The studies described are for the performance of an in vitro diagnostic reagent and its associated analyzer, not an AI/ML powered device. As such, many of the requested categories for AI/ML device studies (e.g., number of experts for ground truth, adjudication method, MRMC studies, training set details) are not applicable to this document.

However, I can extract information related to the acceptance criteria and the device performance for this specific medical device, which is a chemical reagent and an analyzer.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly define "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it presents performance characteristics for the proposed device (Pointe 360 Glucose Hexokinase Reagent and Pointe 360 analyzer) and compares them to the predicate device (Roche Diagnostics Glucose/HK and Hitachi 917). The implicit acceptance criteria are that the Pointe 360's performance is comparable to or better than the predicate device, or within generally accepted analytical performance ranges for glucose measurement.

Characteristic	Implicit Acceptance Criteria (based on comparison to Predicate)	Pointe 360 Glucose Hexokinase Reagent Set (Proposed Device) Performance	Roche Diagnostics Glucose/HK (Predicate Device) Performance
Linearity / Assay Range	Range should be wide enough for clinical utility and comparable to predicate.	$1.0 - 500.0$ mg/dl	$2.0 - 750$ mg/dl (Note: Proposed device has a slightly narrower upper range, but starts lower)
Low Limit of Detection	Should be low for hypoglycemia detection and comparable to predicate.	$1.0$ mg/dl	$2.0$ mg/dl (Note: Proposed device has a lower detection limit, which is generally better)
Interference	No significant interference (>10% variance from control) from common interfering substances.	Bilirubin up to $16.0$ mg/dl: No interference observed.Hemoglobin up to $300$ mg/dl: No interference observed.Lipemia (intralipid) up to $1000$ mg/dl: No interference observed.	Lipemic (Intralipid) levels from $1-1000$ mg/dl (Triglyceride $0-3000$ mg/dl): No significant (>10.0%) interference.Icteric (Bilirubin) levels of $60$ mg/dl: No significant (>10.0%) interference.Hemoglobin levels of $1000$ mg/dl: No significant (>10.0%) interference.
Precision (Within Day)	Low %CV values, comparable to predicate, across different glucose concentrations.	Sample 1 (Mean 81): SD 0.6, CV 0.7 %Sample 2 (Mean 276): SD 1.1, CV 0.4 %Sample 3 (Mean 468): SD 4.9, CV 1.0 %	Sample 1 (Mean 127): CV 1.0 %Sample 2 (Mean 66): CV 1.1 %Sample 3 (Mean 274): CV 0.8 %
Precision (Day to Day)	Low %CV values, comparable to predicate, across different glucose concentrations.	Sample 1 (Mean 81): SD 1.3, CV 1.6 %Sample 2 (Mean 261): SD 3.2, CV 1.2 %Sample 3 (Mean 451): SD 7.5, CV 1.7 %	Sample 1 (Mean 126): CV 1.7 %Sample 2 (Mean 118): CV 1.9 %Sample 3 (Mean 253): CV 1.9 %
Correlation (Serum)	High correlation coefficient (close to 1) and a regression equation close to y=x.	Corr. Coefficient: 0.996Reg. Equation: y = 0.960x + 3.1	Corr. Coefficient: 0.999Reg. Equation: y = 1.02x -2.72
Correlation (Plasma)	High correlation coefficient (close to 1) and a regression equation close to y=x.	Corr. Coefficient: 0.997Reg. Equation: y = 0.977x + 0.6	Not listed

2. Sample size used for the test set and the data provenance

The document does not explicitly state a test set in the way an AI/ML model would have one. Instead, it refers to "samples" for precision studies and "serum/plasma" for correlation.

Precision Studies:
- For "Within Day" precision, Sample 1, 2, and 3 have means of 81, 276, and 468 mg/dl respectively. The 'N' value is missing for the proposed device's precision, but for the predicate, it states 'N=63' for all samples. This suggests a number of replicates were run for each sample level to calculate SD and CV.
- For "Day to Day" precision, Sample 1, 2, and 3 have means of 81, 261, and 451 mg/dl respectively. Again, 'N' is missing for the proposed device, while 'N=63' for the predicate.
Interference Study: The document states "This data was generated using the Pointe 360 analyzer." but does not specify the number of samples or the provenance (e.g., country of origin, retrospective/prospective).
Correlation Study: No specific sample size (N) is given for the correlation studies for either serum or plasma.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is an in vitro diagnostic device that measures a chemical analyte (glucose). "Ground truth" is established by the reference method or accuracy of the measurement itself, not by expert interpretation.

4. Adjudication method for the test set

Not applicable. There is no human interpretation or adjudication involved in the output of this device.

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. This is not an AI/ML powered device, nor does it involve human readers interpreting cases.

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

The device itself is a standalone instrument for performing the glucose assay. Its performance characteristics listed (linearity, LOD, precision, correlation, interference) are all measures of the algorithm/reagent/analyzer system's intrinsic performance. There isn't an "algorithm only" component separate from the physical device in this context.

7. The type of ground truth used

The "ground truth" implicitly used for an in vitro diagnostic device measuring glucose would typically be:

Reference method comparison: Comparison against a highly accurate and precise reference method (e.g., isotope dilution mass spectrometry (IDMS) or specific enzymatic methods). While not explicitly stated here, "Correlation" studies often imply comparison to a gold standard or a well-established method. The regression equations provided (e.g., y = 0.960x + 3.1) suggest a comparison against another method (where 'x' would likely be the reference method result).
Known concentration samples: For linearity, precision, and limit of detection, samples with known, prepared concentrations of glucose are used.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set." The development of the reagent and analyzer involves chemical engineering and instrument design, not machine learning training.

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

Not applicable. No training set for an AI/ML model.

Summary

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510 (k) Summary

Page 1 of 2

Submitter Information Company name: Contact person: Address: Phone: FAX:

E-mail: Date Prepared:

Name of Device Trade Names:

Common Name: Regulation:

Predicate Device Trade/Proprietary Name:

Submitter 510 (k) Number Pointe Scientific, Inc. Ron Jamison 5449 Research Drive Canton, MI 48188 (734) 487-8301 (734) 483-1592 rjamison@pointescientific.com July 24th , 2006

Pointe 360 Glucose Hexokinase Reagent Set Glucose Assay Glucose Test System, Class II, 21 CFR 862.1345

Roche Diagnostics Glucose/HK on the Hitachi 917 Roche Diagnostics Systems Inc. K953847

JUL 1 3 2007

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4. Device Description

5. Intended Use

The Glucose Hexokinase reagent set is intended to be used in a diagnostic laboratory setting by qualified laboratory technologists for the quantitative determination of glucose in human serum and plasma on the Pointe 360 Analyzer. It is for in vitro diagnostic use The determination of glucose in serum and plasma is for use in the diagnosis and only. treatment of diabetes mellitus.

6. Comparison to Predicate Device

The Pointe 360 Glucose Hexokinase reagent set is substantially equivalent to the Roche Diagnostics Glucose/HK on the Hitachi 917 (K953847). Both reagent sets for each analyzer have a similar intended use and functionality.

Characteristics	Liquid Glucose (Proposed Device) andPointe 360 analyzer	Roche Diagnostics Glucose/HK(Predicate Device) and Hitachi 917
Intended Use	The Glucose reagent set is intended to beused in a diagnostic laboratory setting buqualified laboratory technologists for thequantitative determination of glucose inhuman serum.	Enzymatic in vitro test for thequantitative determination of glucosein human serum, plasma, urine andCSF.
Reagent	Hexokinase (yeast) 4000 U/L, G6PDH(Leuconostoc Mesenteroides) 4000 U/L,ATP 6.0 mM, NAD 3.0 mM, Buffer pH 7.5$\pm$ 0.1. Nonreactive stablizers and sodiumazide (0.1%) as preservative.	R1: Tris Buffer: 100mmol/L, pH 7.8;Mg:4mmol/L; ATP $\geq$ 1.7 mmol/L;NADP $\geq$ 1.0 mmol/L; preservativeR2: HEPES buffer, 30 mmol/L, pH7.0; Mg:4mmol/L; HK $\geq$ 8.3 U/ml(yeast); G6PDH $\geq$ 15 U/ml (E. coli);preservative.

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Format	Reagent provided as a ready to use liquid.	Reagents are provided in a ready to use format.
Stability	•Shelf life is 18 months when stored tightly capped at 2-8°C.• Once opened the reagent is stable at least 30 days when properly stored and handled.	Reagent is stable until the expiration date stated on the label at 2-8°C. Opened vial stability is 28 days at 2-8°C. Specific Shelf life not indicated.
Linearity / Assay range	$1.0 - 500.0$ mg/dl	$2.0 - 750$ mg/dl
Low Limit of Detection	$1.0$ mg/dl	$2.0$ mg/dl
Interference	No interference was observed from bilirubin up to $16.0$ mg/dl, hemoglobin up to $300$ mg/dl and lipemia (intralipid) up to $1000$ mg/dl. (using a criteria of >10% variance from control) This data was generated using the Pointe 360 analyzer.	No significant (> 10.0%) lipemic interference found at Intralipid levels from $1-1000$ mg/dl ( $0-3000$ mg/dl Triglyceride). No significant (> 10.0%) icteric interference at Bilirubin levels of $60$ mg/dl. No significant (> 10.0%) Hemoglobin levels of $1000$ mg/dl.
Precision (Within Day)	Mean	SD	CV	Mean	CV
N				N
Sample 1	81	0.6	0.7 %	127	1.0 %	63
Sample 2	276	1.1	0.4 %	66	1.1 %	63
Sample 3	468	4.9	1.0 %	274	0.8 %	63
Precision (Day to Day)	Mean	SD	CV	Mean	CV
N				N
Sample 1	81	1.3	1.6 %	126	1.7 %	63
Sample 2	261	3.2	1.2 %	118	1.9 %	63
Sample 3	451	7.5	1.7 %	253	1.9 %	63
Correlation	Corr. Coefficient	Reg. Equation		Corr. Coefficient	Reg. Equation
Serum	0.996	y = 0.960x + 3.1		0.999	y = 1.02x -2.72
Plasma	0.997	y = 0.977x + 0.6		Not listed

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7. Performance Studies

Testing of the Pointe 360 included validation of the assay as well as the software that is used for the instrument.

8. Conclusion

We feel the data supports a determination that the Pointe Scientific, Inc. Liquid Glucose Hexokinase reagent when used on the Pointe 360 performs and produces data that is substantially equivalent to the products marketed by Roche Diagnostics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 3 2007

Pointe Scientific, Inc. c/o Mr. Ron Jamison Technical Service Manager 5449 Research Drive Canton, MI 48188

Re: K062118

Trade/Device Name: Pointe 360 Glucose Hexokinase Reagent Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: June 20, 2007 Received: June 22, 2007

Dear Mr. Jamison:

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 (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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Indications for Use

510(k) Number (if known):

K062118

Device Name:

Glucose Hexokinase Reagent

Indications For Use:

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

Over-The-Counter Use (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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) kd211Y

Page 1 of 1_

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.