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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Indiko Glucose (HK) system, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance	Performance Accepted
Method Comparison	y = ax + b, where a = 1.00 ± 0.03, b = 0.00 ± 3.6 mg/dl, r ≥ 0.97, max bias at 90 mg/dl 5%	y = 1.01x + 0.7, r = 1, Range: 6 - 700 mg/dl	Yes
Precision (Within run)	Low: CV ≤ 2.0 %Middle: CV ≤ 2.0 %High: CV ≤ 1.8 %	Low: CV 0.7 %Middle: CV 0.6 %High: CV 0.8 %	Yes
Precision (Between run)	Not specified	Low: CV 0.8 %Middle: CV 1.2 %High: CV 0.6 %	Yes
Precision (Total)	Low: CV ≤ 3.5 %Middle: CV ≤ 3.5 %High: CV ≤ 3.0 %	Low: CV 1.6 %Middle: CV 1.5 %High: CV 1.5 %	Yes
Linearity/Measuring Range	Measuring range: 5 - 720 mg/dlMaximum bias from the estimated straight line ± 2.7 mg/dl or ± 5 %.	Measuring range: 5 - 720 mg/dl	Yes
Limit of Blank (LoB)	LoB: < 5.4 mg/dl	LoB: 0.18 mg/dl	Yes
Limit of Quantitation (LoQ)	LoQ: < 9.0 mg/dl	LoQ: 0.54 mg/dl	Yes
Interference (Hemolysate)	No interference found up to 500 mg/dl.Recovery within ± 5 % of initial value.	No interference found up to 1000 mg/dl of hemoglobin.	Yes
Interference (Bilirubin unconjugated)	No interference found up to 23 mg/dl.Recovery within ± 5 % of initial value.	No interference found up to 50 mg/dl conjugated bilirubin.	Yes
Interference (Bilirubin conjugated)	No interference found up to 23 mg/dl.Recovery within ± 5 % of initial value.	No interference found up to 47 mg/dl conjugated bilirubin.	Yes
Interference (Lipemia)	No interference found up to 500 mg/dl.Recovery within ± 5 % of initial value.	No interference found up to 1000 mg/dl of Intralipid®.	Yes

2. Sample size and Data Provenance for Test Set

Sample Size for Method Comparison: 117 samples (n = 117).
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is a "method comparison study" comparing the new device to a predicate device, which typically involves running the same samples on both instruments. Given the manufacturer's location (Finland), it's reasonable to infer the study could have been conducted there, but this is not definitively stated.

3. Number of Experts and Qualifications for Ground Truth of Test Set

This device is a clinical chemistry analyzer with a specific assay for glucose. The "ground truth" for such devices is established by quantitative laboratory measurements, not by expert interpretation of images or clinical cases. Therefore, the concept of "experts establishing ground truth" in the manner of radiologists or pathologists does not directly apply here. Instead, the accuracy of the measurements is compared against a reference (predicate device) and validated against known standards and expected performance.

4. Adjudication Method for Test Set

Not applicable. As this is a quantitative measurement device, there is no "adjudication" in the sense of resolving disagreements between human readers or interpreters. The comparison is objective, based on numerical results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., imaging studies) and is not applicable to an automated clinical chemistry analyzer.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the device's performance characteristics (precision, linearity, limits, interference) were evaluated independently against predefined acceptance criteria. The "method comparison" also evaluates the standalone performance of the Indiko against the predicate device.

7. Type of Ground Truth Used

The ground truth for the performance evaluation of the Indiko Glucose (HK) system is largely established through:
- Comparison to a Predicate Device: The DPC T60i Clinical Chemistry Analyzer (Konelab 60i) was used as a reference for method comparison.
- Internal Validation and Standards: Precision, linearity, limits, and interference studies rely on established laboratory methods, controls, and known concentrations of analytes and interferents.

8. Sample Size for Training Set

The document does not specify a separate "training set" sample size. For clinical chemistry analyzers, the "training" usually refers to the development and calibration of the assay and instrument, which is typically done by the manufacturer during product development, using various internal samples and standards. Unlike AI/ML models, there isn't a distinct "training set" in the context of this 510(k) summary for a traditional analytical instrument.

9. How the Ground Truth for the Training Set was Established

Since a distinct "training set" as understood in AI/ML is not explicitly mentioned for this device, the concept of establishing ground truth for it is not detailed. However, the development of such assays and instruments involves rigorous internal testing, calibration using certified reference materials, and validation across various sample types and concentrations to ensure accuracy and reliability. This process establishes the "ground truth" that the instrument is designed to measure.

Summary

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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: +358-9-32910762 Fax: +358-9-32910300 Email: paivi.sormunen@thermofisher.com

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

+358 (9) 329 100 tel +358 (9) 3291 0500 fax Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki

www.themo.com

Page 1/4 Ver03

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Product Trade Name:	IndikoGlucose (HK)
Common/Usual Name:	Clinical chemistry analyzerGlucose hexokinase assay
Classification Name:	Discrete photometric chemistry analyzer for clinical chemistry(21 CFR § 862.2160, Product code JJE)Glucose test system (21 CFR § 862.1345 Glucose(HK),Product code CFR)
Predicate device:	DPC T60i Clinical Chemistry Analyzer (=Konelab 60ianalyzer), K061107Glucose(HK), K061107

Device description:

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

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 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

+358 (9) 329 100 tel +358 (9) 3291 0500 fax Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki

www.themo.com

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Summary of Technological Characteristics in Comparison to the Predicate Device:

Attribute	Device	Predicate
Reagents	Same	Same
Analyzer
• Discrete PhotometricAnalyzer	Same	Same
• Software Driven	Same	Same
• For clinical laboratoryprofessionals	Same	Same
• Automated dilutions	Same	Same
• Sample reruns	Same	Same

Similarities

Differences

Attribute	Device	Predicate
Reagents Testing Process• Clot detection• ISE testing	NoNot included	YesDirect
Analyzer	Indiko benchtop	DPC T60iKUSTI=Konelab60i, stand alone

Thermo Fisher Scientific Oy

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

+358 (9) 329 100 tel +358 (9) 3291 0500 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	Performanceaccepted
Method comparisonIndiko ClinicalChemistry Analyzer vs.DPC T60 (Konelab 60i)	y = 1.01 x + 0.7r = 1n = 117Range:6 - 700 mg/dl	Y=ax+b, wherea=1.00 ± 0.03b=0.00 ± 3.6 mg/dlr ≥ 0.97max bias at 90 mg/dl 5%	Yes
PrecisionWithin run(Repeatability)	Low: CV 0.7 %Middle: CV 0.6 %High: CV 0.8 %	Low: CV 2.0 %Middle: CV 2.0 %High: CV 1.8 %	Yes
PrecisionBetween run	Low: CV 0.8 %Middle: CV 1.2 %High: CV 0.6 %	Not specified	Yes
PrecisionTotal (Within Device)	Low: CV 1.6 %Middle: CV 1.5 %High: CV 1.5 %	Low: CV 3.5 %,Middle: CV 3.5 %,High: CV 3.0 %	Yes
Linearity/ Measuringrange	Measuring range:5 - 720 mg/dl	Measuring range:5 - 720 mg/dlMaximum bias from theestimated straight line± 2.7 mg/dl or ± 5 %.	Yes
Limit of Blank (LoB),Limit of Quantitation(LoQ)	LoB: 0.18 mg/dlLoQ: 0.54 mg/dl	LoB: < 5.4 mg/dlLoQ: < 9.0 mg/dl	Yes
InterferenceHemolysate	No interference found up to1000 mg/dl of hemoglobin.	No interference found up to500 mg/dl.Recovery within ± 5 % of initialvalue.	Yes
InterferenceBilirubin (unconjugated)	No interference found up to50 mg/dl conjugatedbilirubin.	No interference found up to 23mg/dl.Recovery within ± 5 % of initialvalue.	Yes
InterferenceBilirubin (conjugated)	No interference found up to47 mg/dl conjugatedbilirubin.	No interference found up to 23mg/dl.Recovery within ± 5 % of initialvalue.	Yes
InterferenceLipemia	No interference found up to1000 mg/dl of Intralipid®.	No interference found up to500 mg/dl.Recovery within ± 5 % of initialvalue.	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

+358 (9) 329 100 tel +358 (9) 3291 0500 fax Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.

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 (01) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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 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.

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

Page 1 of 1 _

Regulation Number and Section

§ 862.2160 Discrete photometric chemistry analyzer for clinical use.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.