INDIKO

K110035 · Thermofisher Scientific OY · JJE · Jun 28, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110035
• Device Name: INDIKO
• Applicant: Thermofisher Scientific OY
• Product Code: JJE · Clinical Chemistry
• Decision Date: Jun 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2160
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (HK) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer. 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.

Device Story

Indiko is a benchtop, automated, random-access, discrete photometric clinical chemistry analyzer. It processes human plasma samples to measure glucose concentration using hexokinase (HK) reagent chemistry. The system utilizes a sample disk with an integrated barcode reader for sample identification and a cooled reagent/sample disk. Measurements occur at 37°C using disposable multicell cuvettes. The device is operated by clinical laboratory professionals in a laboratory setting. It incorporates robotics, a computer, and a graphical user interface (Windows 7-based) for data input via touchscreen, mouse, or keyboard. The analyzer automates dilutions and sample reruns. By providing quantitative glucose results, the device assists clinicians in diagnosing and monitoring carbohydrate metabolism disorders, facilitating timely clinical decision-making and patient management.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence is supported by bench testing, including a method comparison study against the predicate (DPC T60i). Results: y = 1.01x + 0.7, r = 1, n = 117, range 6-700 mg/dL. Precision (Total CV) ranged from 1.5% to 1.6%. Linearity was confirmed across 5-720 mg/dL. Interference testing showed no significant impact from hemoglobin (up to 1000 mg/dL), bilirubin (up to 50 mg/dL), or lipemia (up to 1000 mg/dL Intralipid).

Technological Characteristics

Benchtop discrete photometric analyzer; 37°C measurement temperature; cooled reagent/sample disk (10°C below ambient); disposable multicell cuvettes; barcode reader (Code 128, Codabar, Interleaved 2 of 5, Code 39). Software-driven automation for dilutions and reruns. Connectivity via PC interface.

Indications for Use

Indicated for quantitative determination of glucose in human plasma for diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

Regulatory Classification

Identification

A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

Predicate Devices

• Thermo Fisher DPC T60i Clinical Chemistry Analyzer (k061107)
• Thermo Fisher DPC T60i Glucose (HK) assay (k061107)

Submission Summary (Full Text)

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K110035

# 510(k) SUMMARY (As required by section 21 CFR 807.92(c))

JUN 2 8 2011

Thermo Fisher Scientific Oy Ratastie 2 01620 Vantaa Finland Contact person: Päivi Sormunen Director, Operations and QRC Telephone: [phone] Fax: [phone] Email: [e-mail]

Date Prepared:

Contact:

June 09, 2011

Manufacturer:

Thermo Fisher Scientific Oy Ratastie 2 01620 Vantaa Finland

Establishment registration: 9610942

Thermo Fisher Scientific Oy

Ratastie 2 P.O. Box 100 FIN-01621 Vantaa Finland

[phone] tel [phone] fax Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki

www.themo.com

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| Product Trade Name: | Indiko<br>Glucose (HK) |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Clinical chemistry analyzer<br>Glucose hexokinase assay |
| Classification Name: | Discrete photometric chemistry analyzer for clinical chemistry<br>(21 CFR § 862.2160, Product code JJE)<br>Glucose test system (21 CFR § 862.1345 Glucose(HK),<br>Product code CFR) |
| Predicate device: | DPC T60i Clinical Chemistry Analyzer (=Konelab 60i<br>analyzer), k061107<br>Glucose(HK), k061107 |

#### Device description:

The Indiko is automated random access discrete photometric analyzer, capable of performing up to 30 photometric tests.

The sample disk has an integrated barcode reader which allows cup/tube recognition. The barcode reader can read the following codes: code 128, USS Codabar, interleaved 2 of 5 and code 39 with check digit.

Reaction cells are discrete disposable (single use) multicell cuvettes with 10 reaction measurement cells in a row. On-board capacity of 36 multicell cuvettes (equal to 360 reaction cells), with continuous loading capability, typically 2 hours walk-away time. The quality of the reaction cells is checked at the start of the routine work automatically. The measurements are performed at 37℃.

The analyzer incorporates robotics, computer, and communication technology to render simple and reliable long-term operation. The operating system works with Windows® 7. The user interface software is graphical. The data input can be done online or by touch screen or mouse or keyboard.

Reagents are liquid, the reagent bottles are placed on the reagent/sample disk, which holds maximum 30 positions, the reagent/sample disk is cooled 10℃ below ambient temperature.

#### Statement of Intended Use

The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.

The Indiko Glucose (HK) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer.

Ratastie 2 P.O. Box 100 FIN-01621 Vantaa Finland

[phone] tel [phone] fax Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki

www.themo.com

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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.

# Summary of Technological Characteristics in Comparison to the Predicate Device:

| Attribute | Device | Predicate |
|--------------------------------------------|--------|-----------|
| Reagents | Same | Same |
| Analyzer | | |
| • Discrete Photometric<br>Analyzer | Same | Same |
| • Software Driven | Same | Same |
| • For clinical laboratory<br>professionals | Same | Same |
| • Automated dilutions | Same | Same |
| • Sample reruns | Same | Same |

#### Similarities

# Differences

| Attribute | Device | Predicate |
|---------------------------------------------------------------|--------------------|-----------------------------------------------|
| Reagents Testing Process<br>• Clot detection<br>• ISE testing | No<br>Not included | Yes<br>Direct |
| Analyzer | Indiko benchtop | DPC T60i<br>KUSTI=Konelab<br>60i, stand alone |

Thermo Fisher Scientific Oy

Ratastie 2 P.O. Box 100
FIN-01621 Vantaa Finland

[phone] tel [phone] fax Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki

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### Summary of non-clinical testing

Design verification and validation testing was performed to ensure that the design specifications and customer requirements were met. A method comparison study was performed to compare the new device to the predicate device to support a determination of substantial equivalence. Below is a summary of performance testing results:

| Performance Characteristics | | | |
|-----------------------------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------|
| Glucose (HK) | | | |
| Performance experiment | Result | Acceptance criteria | Performance<br>accepted |
| Method comparison<br>Indiko Clinical<br>Chemistry Analyzer vs.<br>DPC T60 (Konelab 60i) | y = 1.01 x + 0.7<br>r = 1<br>n = 117<br>Range:<br>6 - 700 mg/dl | Y=ax+b, where<br>a=1.00 ± 0.03<br>b=0.00 ± 3.6 mg/dl<br>r ≥ 0.97<br>max bias at 90 mg/dl 5% | Yes |
| Precision<br>Within run<br>(Repeatability) | Low: CV 0.7 %<br>Middle: CV 0.6 %<br>High: CV 0.8 % | Low: CV 2.0 %<br>Middle: CV 2.0 %<br>High: CV 1.8 % | Yes |
| Precision<br>Between run | Low: CV 0.8 %<br>Middle: CV 1.2 %<br>High: CV 0.6 % | Not specified | Yes |
| Precision<br>Total (Within Device) | Low: CV 1.6 %<br>Middle: CV 1.5 %<br>High: CV 1.5 % | Low: CV 3.5 %,<br>Middle: CV 3.5 %,<br>High: CV 3.0 % | Yes |
| Linearity/ Measuring<br>range | Measuring range:<br>5 - 720 mg/dl | Measuring range:<br>5 - 720 mg/dl<br>Maximum bias from the<br>estimated straight line<br>± 2.7 mg/dl or ± 5 %. | Yes |
| Limit of Blank (LoB),<br>Limit of Quantitation<br>(LoQ) | LoB: 0.18 mg/dl<br>LoQ: 0.54 mg/dl | LoB: < 5.4 mg/dl<br>LoQ: < 9.0 mg/dl | Yes |
| Interference<br>Hemolysate | No interference found up to<br>1000 mg/dl of hemoglobin. | No interference found up to<br>500 mg/dl.<br>Recovery within ± 5 % of initial<br>value. | Yes |
| Interference<br>Bilirubin (unconjugated) | No interference found up to<br>50 mg/dl conjugated<br>bilirubin. | No interference found up to 23<br>mg/dl.<br>Recovery within ± 5 % of initial<br>value. | Yes |
| Interference<br>Bilirubin (conjugated) | No interference found up to<br>47 mg/dl conjugated<br>bilirubin. | No interference found up to 23<br>mg/dl.<br>Recovery within ± 5 % of initial<br>value. | Yes |
| Interference<br>Lipemia | No interference found up to<br>1000 mg/dl of Intralipid®. | No interference found up to<br>500 mg/dl.<br>Recovery within ± 5 % of initial<br>value. | Yes |

## Summary of Clinical testing

No additional clinical evaluations of the devices for use have been conducted.

#### Conclusion

The Indiko clinical chemistry analyzer and Glucose (HK) reagent kit are substantially equivalent to DPC T60i clinical chemistry analyzer and Glucose (HK) kit respectively.

Ratastie 2 P.O. Box 100 FIN-01621 Vantaa Finland

[phone] tel [phone] fax Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

JUN 2 8 2011

Thermo Fisher Scientific Oy c/o Ms. Päivi Sormunen Director of Operations and Quality, Regulatory and Compliance CDD Finland Ratastic 2 Vantaa. 01620 Finland

Re: k110035

Trade/Device Name: Indiko Clinical Chemistry Analyzer, Indiko Glucose (HK) Regulation Number: 21 CFR 862. 1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR, JJE Dated: June 15, 2011 Received: June 15, 2011

Dear Ms. Sormunen:

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 class II (Special Controls), 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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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premy aket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/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/cdrh/industry/support/index.html.

Sincerely yours.

G.C.

Courtney Harper, Ph.D. 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): k110035

#### Indiko Clinical Chemistry Analyzer Device Name: Indiko Glucose(HK)

Indications for Use:

The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.

The Indiko Glucose (HK) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer.

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.

Prescription Use X (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 OF NEEDED)

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

Signature

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

510(k) 10035

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