POINTE 360

K062118 · Pointe Scientific, Inc., · CFR · Jul 13, 2007 · Clinical Chemistry

Device Facts

• Record ID: K062118
• Device Name: POINTE 360
• Applicant: Pointe Scientific, Inc.,
• Product Code: CFR · Clinical Chemistry
• Decision Date: Jul 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

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 only. The determination of glucose in serum and plasma is for use in the diagnosis and treatment of diabetes mellitus.

Device Story

Pointe 360 is a computerized benchtop laboratory instrument; automates assay processing including incubation, reagent delivery, mixing, optical reading, calculation, data storage, and reporting. Uses liquid glucose hexokinase reagent set to measure glucose in human serum and plasma. Operated by qualified laboratory technologists in diagnostic laboratory settings. Instrument performs optical analysis; software calculates glucose concentration based on absorbance. Output provided to healthcare providers for diagnosis and treatment of diabetes mellitus. Benefits include automated, standardized glucose quantification.

Clinical Evidence

Bench testing only. Precision evaluated over 20 days (within-day CV 0.4-1.0%; day-to-day CV 1.2-1.7%). Linearity assessed across 1.0-500.0 mg/dL range. Method comparison with predicate using 100 serum samples (r=0.996) and 99 plasma samples (r=0.997). Interference testing confirmed no significant bias from bilirubin, hemoglobin, or lipemia.

Technological Characteristics

Enzymatic hexokinase assay; photometric detection at 340nm. Benchtop analyzer (Pointe 360) performs incubation, reagent delivery, mixing, and optical reading. Software design follows IEEE 1016-1987 and J-Std 016/IEEE 1498 standards.

Indications for Use

Indicated for the quantitative determination of glucose in human serum and plasma for the diagnosis and treatment of diabetes mellitus in a laboratory setting.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Roche Diagnostics Glucose/HK on the Hitachi 917 (k953847)

Submission Summary (Full Text)

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# 510 (k) Summary

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

E-mail: Date Prepared:

2. Name of Device Trade Names:

Common Name: Regulation:

3. Predicate Device Trade/Proprietary Name:

Submitter 510 (k) Number Pointe Scientific, Inc. Ron Jamison 5449 Research Drive Canton, MI 48188 [phone] [phone] [e-mail] 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

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.

# 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) and<br>Pointe 360 analyzer | Roche Diagnostics Glucose/HK<br>(Predicate Device) and Hitachi 917 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Glucose reagent set is intended to be<br>used in a diagnostic laboratory setting bu<br>qualified laboratory technologists for the<br>quantitative determination of glucose in<br>human serum. | Enzymatic <i>in vitro</i> test for the<br>quantitative determination of glucose<br>in human serum, plasma, urine and<br>CSF. |
| Reagent | Hexokinase (yeast) 4000 U/L, G6PDH<br>(Leuconostoc Mesenteroides) 4000 U/L,<br>ATP 6.0 mM, NAD 3.0 mM, Buffer pH 7.5<br>$\pm$ 0.1. Nonreactive stablizers and sodium<br>azide (0.1%) as preservative. | R1: Tris Buffer: 100mmol/L, pH 7.8;<br>Mg:4mmol/L; ATP $\geq$ 1.7 mmol/L;<br>NADP $\geq$ 1.0 mmol/L; preservative<br>R2: HEPES buffer, 30 mmol/L, pH<br>7.0; Mg:4mmol/L; HK $\geq$ 8.3 U/ml<br>(yeast); G6PDH $\geq$ 15 U/ml (E. coli);<br>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.<br>• 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 [phone]. 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 [phone] or [phone] 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:

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.

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

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