ADVIA CHEMISTRY GLUH_3 REAGENTS

K120681 · Siemens Healthcare Diagnostics, Inc. · CFR · May 15, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120681
• Device Name: ADVIA CHEMISTRY GLUH_3 REAGENTS
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: CFR · Clinical Chemistry
• Decision Date: May 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

For in vitro diagnostic use in the quantitative determination of glucose in human serum, plasma, urine, and cerebrospinal fluid (CSF) on the ADVIA 1650 Chemistry System. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and insulin overdose. For in vitro diagnostic use only. For prescription use only.

Device Story

ADVIA Chemistry Glucose Hexokinase 3 (GLUH 3) reagent is an in vitro diagnostic assay for quantitative glucose measurement. The device uses a two-component reagent system: Reagent 1 (buffer, ATP, NAD) is added to the sample to establish baseline absorbance and correct for interference; Reagent 2 is added to initiate glucose conversion via hexokinase and glucose-6-phosphate dehydrogenase enzymes. The resulting absorbance change at 340/410 nm is proportional to glucose concentration. Operated by laboratory personnel on ADVIA Chemistry systems, the assay provides quantitative results used by clinicians to diagnose and manage carbohydrate metabolism disorders. This specific submission expands the cleared plasma types to include Sodium Fluoride/Potassium Oxalate, in addition to previously cleared Li-Heparin and K-EDTA.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical matrix comparison testing. 82 matched serum/plasma sample sets (56 patient, 26 spiked/diluted) were analyzed on the ADVIA 1650 Chemistry System. Linear regression yielded y = 1.011x + 0.78, r=0.999, with 95% CI for slope 1.003–1.019. All other analytical performance characteristics (precision, linearity, specificity) were previously cleared under k101854.

Technological Characteristics

Two-component liquid reagent system. Principle: Hexokinase/glucose-6-phosphate dehydrogenase enzymatic method. Analyte: Glucose. Assay range: 4-700 mg/dL. Instrumentation: ADVIA Chemistry systems. Sample types: Serum, urine, CSF, and plasma (Li-Heparin, K-EDTA, Na-Fluoride/K-Oxalate).

Indications for Use

Indicated for quantitative glucose determination in human serum, plasma, urine, and CSF to diagnose/treat carbohydrate metabolism disorders (diabetes mellitus, neonatal/idiopathic hypoglycemia, insulin overdose).

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

• ADVIA® Chemistry GLUH_3 Reagent (k101854)

Submission Summary (Full Text)

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K120681

#### 510(k) Summary

# MAY 1 5 2012

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.

| Submitter's Name: | Kira Gordon<br>Siemens Healthcare Diagnostics Inc.<br>511 Benedict Ave,<br>Tarrytown, NY 10591 | | | | |
|--------------------------|------------------------------------------------------------------------------------------------|--|--|--|--|
| Date of Preparation: | May 10, 2012 | | | | |
| Name of Product: | ADVIA® Chemistry Glucose Hexokinase_3 (GLUH_3) reagen | | | | |
| FDA Classification Name: | Glucose test system. | | | | |

#### Predicate Device:

The following table describes the predicate devices, device classification, regulation and product code associated with this pre-market notification:

| New Product | Predicate Device | 510(k) number | Device Class | Regulation | Product Code |
|----------------------------------------------------------------------|---------------------------------------|---------------|--------------|------------|--------------|
| ADVIA®<br>Chemistry<br>GLUH_3 Reagent<br>(additional<br>plasma type) | ADVIA®<br>Chemistry<br>GLUH_3 Reagent | k101854 | Class II | 862.1345 | CFR |

#### Device Description: 1

The ADVIA Chemistry Glucose Hexokinase 3 (GLUH 3) method uses a two-component reagent. Sample is added to Reagent 1, which contains the buffer, ATP, and NAD. Absorbance readings of the sample in Reagent 1 are taken and are used to correct for interfering substances in the sample. Reagent 2 is added, which initiates the conversion of glucose and the development of absorbance at 340/410 nm. The difference between the absorbance in Reagent 1 and Reagent 2 is proportional to the glucose concentration.

## Intended Use:

For in vitro diagnostic use in the quantitative determination of glucose in human serum, plasma, urine and CSF on the ADVIA Chemistry systems. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and insulin overdose.

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## Comparison to Predicate Device:

A comparison of the important features of the devices are provided in the following table:

| Item | New Device | Predicate Device |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte | Glucose | Same |
| Intended Use | For <i>in vitro</i> diagnostic use in the<br>quantitative determination of glucose in<br>human serum, plasma, urine and CSF on<br>the ADVIA Chemistry systems. Such<br>measurements are used in the diagnosis<br>and treatment of carbohydrate<br>metabolism disorders including diabetes<br>mellitus, neonatal hypoglycemia,<br>idiopathic hypoglycemia, and insulin<br>overdose | Same |
| Sample type | human serum, plasma, urine and CSF | Same |
| Plasma type | Li-Heparin, K-EDTA and<br>Na-Fluoride/K-Oxalate | Li-Heparin, K-EDTA |
| Instrument to<br>be used | ADVIA Chemistry | Same |
| Method<br>Principle | based on the method by Slein using<br>hexokinase and glucose-6-phosphate<br>dehydrogenase enzymes. | Same |
| Calibrators | Siemens Healthcare Diagnostics<br>Chemistry Calibrator REF 09784096 | Same |
| Assay range | 4 -700 mg/dL | Same |
| Accuracy /<br>Correlation | Serum:<br>$Y = 1.001x + 0.3$ ; N=99 r=1.000<br>Plasma (Li-Heparin):<br>$Y = 1.001x + 0.2$ , N=88; r=1.000<br>Plasma (K-EDTA)<br>$Y = 1.002x - 0.0$ , N=87; r=1.000<br>Plasma (Na Fluoride/Potassium Oxalate)<br>$Y = 1.011x + 0.8$ , N=82; r=0.999<br>CSF:<br>$Y = 1.005x - 0.1$ , N=113; r=1.000<br>Urine: | Serum:<br>Same<br>Plasma (Li-Heparin):<br>same<br>Plasma (K-EDTA)<br>Same<br>Plasma (Na Fluoride/Potassium Oxalate)<br>none<br>CSF:<br>Same<br>Urine:<br>Same |

## Comments on Substantial Equivalence:

1. Analytical performance:

- a. Precision/Reproducibility:
Not applicable for this modification.

b. Linearity/assay reportable range:

Not applicable for this modification.

- c. Traceability (controls, calibrators, or method): Not applicable for this modification.

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d. Detection limit (functional sensitivity):

Not applicable for this modification.

- e. Analytical specificity:
Not applicable for this modification.

- f. Assay cut-off:
Not applicable.

## 2. Comparison studies: ·

a. Method comparison with predicate device:

Not applicable for this modification.

b. Matrix comparison: .

56 matched serum and plasma (Sodium Fluoride/Potassium Oxalate) samples were evaluated. Some of these samples were spiked and/or diluted. There were a total of 82 data-points included in calculations. Matrix

- Comparison between serum and Na FI plasma tubes using the ADVIA 1650 Chemistry GLUH_3 assay gave the following correlation statistics using the
linear regression calculations:

x - serum, y -Sodium Fluoride/Potassium Oxalate plasma

| Regression Equation | | | Sample Range |
|---------------------------------|------|-------|--------------|
| v=1.011 * x + 0.8 | | | |
| Slope 95% CI: 1.003 to 1.019 | 6.13 | 0.999 | ર-601 |
| Intercept 95% Cl: -1.18 to 2.73 | | | |

3. Clinical studies:

a. Clinical sensitivity:

Not applicable for this submission.

b. Clinical specificity:

Not applicable for this submission.

- 4. Clinical cut-off:
Not applicable for this submission.

5. Expected values/Reference range:

Not applicable for this modification.

#### Conclusion:

Comparative testing of the ADVIA 1650 Chemistry Glucose Hexokinase 3 reagent using Sodium Fluoride/Potassium Oxalate plasma type demonstrates substantially equivalent performance to the GLUH_3 reagent using serum as a plasma type cleared under k101854.

Kira Gordon Regulatory Affairs & Compliance May 10, 2012

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in all capital letters.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics Inc. c/o Kira Gordon 511 Benedict Ave Tarrytown, N.Y. 10509

MAY 1 5 2012

Re: k120681

> Trade Name: Advia® Chemistry GLUH 3 Reagent Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CFR Dated: March 2, 2012 Received: March 6, 2012

Dear Ms Gordon:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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#### Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...

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 http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

N. Kim, Ph.D.

Couriney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices 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):

Device Name:

ADVIA® Chemistry GLUH 3 Reagent

Indication For Use:

For in vitro diagnostic use in the quantitative determination of glucose in human serum, plasma, urine and CSF on the ADVIA Chemistry systems. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and insulin overdose.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

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

510(k) R 120681

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