(174 days)
Not Found
No
The description focuses on standard automated clinical chemistry analyzer technology and does not mention AI or ML.
No
The device is an in vitro diagnostic (IVD) device used to measure the concentration of glucose in human plasma, which aids in the diagnosis and treatment of conditions, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section states: "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." This explicitly indicates its use for diagnosis.
No
The device description clearly outlines a physical analyzer with robotics, a sample disk, reaction cells, and a cooling system, indicating it is a hardware device with integrated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states 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." This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details a clinical chemistry analyzer designed to measure analytes in samples, which is a typical function of an IVD.
- Intended User/Care Setting: The intended user is "clinical laboratory professionals," indicating use in a clinical setting for diagnostic testing.
- Performance Studies: The document includes performance studies (method comparison, precision, linearity, etc.) which are standard requirements for demonstrating the analytical performance of an IVD.
- Predicate Device(s): The mention of predicate devices (other clinical chemistry analyzers and glucose tests) further confirms its classification as an IVD, as predicate devices are used for comparison in regulatory submissions for new IVDs.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JJE, CFR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For clinical laboratory professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Description of the test set: Method comparison Indiko Clinical Chemistry Analyzer vs. DPC T60 (Konelab 60i)
Sample size: n = 117
Data source: Not Found
Annotation protocol: Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Method comparison, Precision (Within run, Between run, Total), Linearity/Measuring range, Limit of Blank (LoB), Limit of Quantitation (LoQ), Interference (Hemolysate, Bilirubin (unconjugated), Bilirubin (conjugated), Lipemia)
Sample Size: 117 for method comparison. Not specified for other studies.
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key Results:
Method comparison: y = 1.01 x + 0.7, r = 1. Range: 6 - 700 mg/dl. Acceptance criteria: 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%. Performance accepted.
Precision Within run: Low: CV 0.7 %, Middle: CV 0.6 %, High: CV 0.8 %. Acceptance criteria: Low: CV 2.0 %, Middle: CV 2.0 %, High: CV 1.8 %. Performance accepted.
Precision Between run: Low: CV 0.8 %, Middle: CV 1.2 %, High: CV 0.6 %. (No acceptance criteria specified). Performance accepted.
Precision Total (Within Device): Low: CV 1.6 %, Middle: CV 1.5 %, High: CV 1.5 %. Acceptance criteria: Low: CV 3.5 %, Middle: CV 3.5 %, High: CV 3.0 %. Performance accepted.
Linearity/Measuring range: 5 - 720 mg/dl. Acceptance criteria: 5 - 720 mg/dl, Maximum bias from the estimated straight line ± 2.7 mg/dl or ± 5 %. Performance accepted.
LoB: 0.18 mg/dl, LoQ: 0.54 mg/dl. Acceptance criteria: LoB:
§ 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.
0
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
Page 1/4 Ver03
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| Product Trade Name: | Indiko
Glucose (HK) |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Clinical chemistry analyzer
Glucose 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 60i
analyzer), K061107
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
+358 (9) 329 100 tel +358 (9) 3291 0500 fax Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki
2
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 | ||
| Analyzer | Same | Same |
| • Software Driven | Same | Same |
| • For clinical laboratory | ||
| professionals | Same | Same |
| • Automated dilutions | Same | Same |
| • Sample reruns | Same | Same |
Similarities
Differences
| Attribute | Device | Predicate |
|---|---|---|
| Reagents Testing Process | ||
| • Clot detection | ||
| • ISE testing | No | |
| Not included | Yes | |
| Direct | ||
| Analyzer | Indiko benchtop | DPC T60i |
| KUSTI=Konelab | ||
| 60i, 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
3
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 |
| accepted | |||
| Method comparison | |||
| Indiko Clinical | |||
| Chemistry Analyzer vs. | |||
| DPC T60 (Konelab 60i) | y = 1.01 x + 0.7 | ||
| r = 1 | |||
| n = 117 | |||
| Range: | |||
| 6 - 700 mg/dl | 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% | Yes | ||
| Precision | |||
| Within 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 | ||
| Precision | |||
| Between run | Low: CV 0.8 % | ||
| Middle: CV 1.2 % | |||
| High: CV 0.6 % | Not specified | Yes | |
| Precision | |||
| Total (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/ Measuring | |||
| range | Measuring range: | ||
| 5 - 720 mg/dl | Measuring range: | ||
| 5 - 720 mg/dl | |||
| Maximum bias from the | |||
| estimated straight line | |||
| ± 2.7 mg/dl or ± 5 %. | Yes | ||
| Limit of Blank (LoB), | |||
| Limit of Quantitation | |||
| (LoQ) | LoB: 0.18 mg/dl | ||
| LoQ: 0.54 mg/dl | LoB: |