Lithium is intended for in vitro diagnostic use in the quantitative determination of the lithium concentration in human serum on T60 Clinical Chemistry Analyzers. Measurements are used as an aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder).

Theophylline is intended for quantitative in vitro diagnostic determination of the theophylline concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to help ensure proper therapy.

The ISE Calibrators 1 and 2 & 3 are intended for calibration of ion selective electrodes for quantitative measurements of potassium, sodium and chloride in human serum or plasma and lithium in human serum. For the in vitro diagnostic use on the T60 analyzer.

TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981649 Theophylline assay on T60 Analyzer.

Device Description

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AI/ML Overview

The provided document describes the acceptance criteria and study results for two devices: the Lithium Micro Volume Electrode and Theophylline. Both are in vitro diagnostic devices for quantitative determination in human serum on T60 Clinical Chemistry Analyzers.

Here's a breakdown of the requested information for each device:

Lithium Micro Volume Electrode

1. Table of Acceptance Criteria and Reported Device Performance

The document compares the new device with a predicate device (Infinity™ Lithium Reagent for Olympus®). Performance metrics are presented for both devices, allowing for implicit comparison rather than explicit acceptance criteria.

Attribute	Acceptance Criteria (New Device) - Implied from Predicate	Reported Device Performance (New Device)
Intended Use	Quantitative determination of lithium concentration in human serum.	For in vitro diagnostic use in the quantitative determination of the lithium concentration in human serum on T60 analyzer.
Indication for Use	Aid in management of individuals taking lithium for mental disturbances.	Aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder).
Assay Protocol	(Predicate: Spectrophotometric)	Potentiometric
Traceability/Standardization	(Predicate: Not specified)	NIST SRM 924
Sample Type	Serum	Serum
Measuring Range	Similar to predicate (0.04 - 3.00 mmol/l)	0.2 - 4.0 mmol/l
Precision (Within run)	Level 0.57 mmol/l: CV(%) = 0.9; Level 1.83 mmol/l: CV(%) = 0.7 (predicate)	Level 0.95 mmol/l: SD = 0.008, CV(%) = 0.9; Level 1.86 mmol/l: SD = 0.017, CV(%) = 0.9
Precision (Between run)	(No explicit predicate for between-run provided)	Level 0.95 mmol/l: SD = 0.009, CV(%) = 0.9; Level 1.86 mmol/l: SD = 0.009, CV(%) = 0.5
Precision (Total)	Level 0.57 mmol/l: CV(%) = 1.9; Level 1.83 mmol/l: CV(%) = 1.3 (predicate)	Level 0.95 mmol/l: SD = 0.020, CV(%) = 2.1; Level 1.86 mmol/l: SD = 0.039, CV(%) = 2.1
Method Comparison (Correlation)	r = 0.9956 (predicate)	r = 0.999
Method Comparison (Equation)	y = 1.01x - 0.007 (predicate)	y = 0.98x - 0.01
Method Comparison (Range)	0.11 - 1.73 mmol/l (predicate)	0.25 - 4.09 mmol/l
Limitations (Bilirubin)	No significant interference up to 45 mg/dl (predicate)	No interference found up to 41 mg/dl (700 µmol/l) of conjugated Bilirubin
Limitations (Lipemia)	No significant interference up to 22.6 mmol/l (2000 mg/dl) (predicate)	No interference found up to 1000 mg/dl (10 g/l) of Intralipid®
Limitations (Hemolysate/Hemoglobin)	No interference up to 2 g/l (predicate)	No interference found up to 1000 mg/dl (10 g/l) of hemoglobin

2. Sample size used for the test set and the data provenance

Sample Size: N = 117 samples were used for the method comparison study.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's a 510(k) submission, it's typically clinical samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device performs quantitative chemical analysis, where instrument readings and reference methods (predicate device for comparison) establish the ground truth, not human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for quantitative chemical analysis. Ground truth is established by the reference method (predicate device in this case), not by expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a standalone diagnostic device for chemical analysis, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the device (Lithium Micro Volume Electrode) is a standalone diagnostic tool. Its performance is measured directly against a predicate device and established analytical parameters like precision.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the test set was established by a predicate device (NOVA ISE), which is a legally marketed device for lithium measurement. The method comparison data shows correlation against this established method.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Theophylline

1. Table of Acceptance Criteria and Reported Device Performance

The document compares the new device with a predicate device (The CEDIA® Theophylline II Assay). Performance metrics are presented for both devices for implicit comparison rather than explicit acceptance criteria.

Attribute	Acceptance Criteria (New Device) - Implied from Predicate	Reported Device Performance (New Device)
Intended Use	Quantitative determination of theophylline concentration in human serum for diagnosis and treatment of overdose and therapy monitoring.	For in vitro diagnostic use in the quantitative determination of the theophylline concentration in human serum on T60 analyzer. Measurements are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to help ensure proper therapy.
Indication for Use	Same as intended use.	Same as intended use.
Assay Protocol	Homogeneous enzyme immunoassay using recombinant DNA technology.	Assay uses recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system.
Traceability/Standardization	(Predicate: Not specified)	The calibration values are traceable to USP reference materials prepared gravimetrically to drug-free human serum.
Sample Type	Serum	Serum
Measuring Range	Between 0.8 µg/ml and approx. 40 µg/ml (predicate)	From 1.4 µg/ml or 7.8 µmol/l to 40 µg/ml or 222 µmol/l.
Precision (Within run)	Level 5.1 µg/ml: CV(%) = 3.3; Level 15.1 µg/ml: CV(%) = 1.9; Level 29.3 µg/ml: CV(%) = 1.3 (predicate)	Level 4.4 µg/ml: SD = 0.17, CV(%) = 3.9; Level 13.8 µg/ml: SD = 0.21, CV(%) = 1.5; Level 28.1 µg/ml: SD = 0.21, CV(%) = 0.8
Precision (Total)	Level 5.1 µg/ml: CV(%) = 5.1; Level 15.1 µg/ml: CV(%) = 2.4; Level 29.3 µg/ml: CV(%) = 2.0 (predicate)	Level 4.4 µg/ml: SD = 0.35, CV(%) = 8.0; Level 13.8 µg/ml: SD = 0.59, CV(%) = 4.3; Level 28.1 µg/ml: SD = 0.87, CV(%) = 3.1
Method Comparison (Correlation)	r = 0.997 (predicate)	r = 0.998
Method Comparison (Equation)	y = 1.01x - 0.41 (predicate)	y = 0.989x + 0.05
Method Comparison (Range)	0.9 - 37.4 µg/ml (predicate)	1.1 - 37.7 µg/ml
Limitations (Bilirubin)	No significant interference up to 66 mg/dl (predicate)	No interference found up to 58 mg/dl (1000 µmol/l)
Limitations (Hemoglobin)	No significant interference up to 1000 mg/dl (predicate)	No interference found up to 1000 mg/dl (10 g/l)
Limitations (Lipemia)	No significant interference up to L index of 1000 (approx. 2000 mg/dl triglycerides) (predicate)	No interference found up to 1000 mg/dl (10 g/l) of Intralipid®
Limitations (Uremic patients)	Should not be used due to cross-reactivity with 1,3-Dimethyluric Acid (predicate)	Due to cross-reactivity with 1,3-Dimethyluric Acid, the Theophylline assay should not be used to quantitate samples from uremic patients.

2. Sample size used for the test set and the data provenance

Sample Size: N = 133 samples were used for the method comparison study.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, as a 510(k) submission, it typically involves clinical samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device performs quantitative chemical analysis, where instrument readings and reference methods (predicate device for comparison) establish the ground truth, not human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for quantitative chemical analysis. Ground truth is established by the reference method (predicate device in this case), not by expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a standalone diagnostic device for chemical analysis, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the device (Theophylline) is a standalone diagnostic tool. Its performance is measured directly against a predicate device and established analytical parameters like precision.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the test set was established by a commercially available fluorescence polarization immunoassay (the predicate device). The method comparison data shows correlation against this established method.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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510(k) SUMMARY

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

The assigned 510(k) number is: K063705

A. Introduction:

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

B. Submitter's information

Name:	Thermo Fisher Scientific Oy
Address:	Ratastie 2P.O. Box 100FIN-01621 VantaaFinland
Phone:	+358 (9) 329 100 tel
Fax:	+358 (9) 3291 0300 fax
Contact person:	Päivi Sormunen, Vice President of QRC
Date of Preparation:	October 5, 2007

c. Device name

Proprietary name:	Lithium Micro Volume Electrode
Common name:	Lithium
Classification:	II
Class:	Toxicology
Product Code:	NDW

Proprietary name: Theophylline Common name: Theophylline Classification: II Class: Toxicology Product Code: Kra

Proprietary name: ISE Calibrator 1, ISE Calibrator 2&3 (FDA Clearance number K061107) Common name: Calibrator

Classification: II Class: Clinical Chemistry (75) Product Code: JIX
Proprietary name: TDM Calibration set B Common name: Calibrator Classification: II Class: Toxicology Product Code: DKB

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D. Intended Use

Lithium

For in vitro diagnostic use in the quantitative determination of the lithium concentration in human serum on T60 analyzer.

Theophylline

For in vitro diagnostic use in the quantitative determination of the theophylline concentration in human serum on T60 analyzer. Measurements are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to help ensure proper therapy.

ISE Calibrator 1 and ISE Calibrator 2&3

For in vitro diagnostic use in T60 analyzer. The ISE Calibrator 1 and 2&3 are intended for calibration of ion selective electrodes for quantitative measurements of potassium, sodium and chloride in serum or plasma and lithium in serum.

TDM Calibration set B

For in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981649 Theophylline assay on T60 Analyzer.

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E. Indications for use

For ISE Calibrator 1, ISE Calibrator 2&3 and TDM Calibration set B see intended use

F. Substantial Equivalence

Thermo Electron, Australia/U.S.A The Infinity™ Lithium Reagent for Olympus® Analysers. (K003583)

Microgenics Corporation item: The CEDIA® Theophylline II Assay. (K961462)

G. Substantial equivalence -similarities

Lithium Micro Volume Electrode is substantially equivalent to other devices legally marketed in United Staes. We claim equivalence to the Thermo Electron Australia/U.S.A. The InfinityTM Lithium Reagent for Olympus® Analysers.

Theophylline is substantially equivalent to other devices legally marketed in United States. We claim equivalence to the Microgenics Corporation item, the CEDIA® Theophylline II Assay

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The following table compares the Lithium with the predicate assay H.

Table 1 Lithium
Attribute	New device #1Lithium Micro Volume ElectrodeCalibrator partISE Calibrator 1 and ISECalibrator 2 & 3	Predicate device #1Infinity™ Lithium Reagent forOlympus® (K003583)Thermo Trace TR66002Calibrator partLithium Standard TR66901
Intended Use	For in vitro diagnostic use in thequantitative determination of thelithium concentration in humanserum on T60 analyzer.	Reagent for the quantitativedetermination of Lithiumconcentration in human serum andplasma on the OlympusAU400/AU600/AU640/AU2700/AU5400 chemistry analysers.
Indication for Use	Lithium is intended for in vitrodiagnostic use in the quantitativedetermination of the lithiumconcentration in human serum onT60 Clinical Chemistry Analyzers.Measurements are used as an aidin the management of individualstaking lithium for the treatment ofmental disturbances, such as manic-depressive illness (bipolar disorder).	Lithium is widely used in thetreatment of manic depressivepsychosis.
Assay Protocol	Potentiometric	Spectrophotometric
Traceability/Standardization	NIST SRM 924	-
Sample Type	Serum	Serum or EDTA-plasma
Reagent Storage	Calibrators in unopened bags or vialsare stable at 2...30 °C until theexpiration date printed on the label.Electrodes have to be stored at2...8 °C before installation.	The unopened reagents are stableuntil the expiration date when storedat 2-8°C.
Expected Values	Therapeutic rangeAccording to source (1) suggestedrange is:0.6 - 1.2 mmol/lConcentrations of 1.2 to 1.5 mmol/lsignify a warning range andconcentrations over 1.5 mmol/lindicate a significant risk ofintoxication.	12 hour post dose troughconcentration: 1.0 - 1.2 mmol/lValues >1.5 mmol/l 12 hours afterdose indicates a significant risk ofintoxication.
Lithium
Attribute	New device #1Lithium Micro Volume ElectrodeCalibrator partISE Calibrator 1 and ISECalibrator 2 & 3	Predicate device #1Infinity™ Lithium Reagent forOlympus® (K003583)Thermo Trace TR66002Calibrator partLithium Standard TR66901
Instrument	T60 and DPC T60i, DPC T60i Kusti	Olympus AU 400
Measuring Range	0.2 - 4.0 mmol/l	0.04 - 3.00 mmol/l
Precision	Within runLevel 0.95 mmol/lSD = 0.008CV(%) = 0.9Level 1.86 mmol/lSD = 0.017CV(%) = 0.9Between runLevel 0.95 mmol/lSD = 0.009CV(%) = 0.9Level 1.86 mmol/lSD = 0.009CV(%) = 0.5TotalLevel 0.95 mmol/lSD = 0.020CV(%) = 2.1Level 1.86 mmol/lSD = 0.039CV(%) = 2.1	Within runLevel 0.57 mmol/lSD = 0.005CV(%) = 0.9Level 1.83 mmol/lSD = 0.012CV(%) = 0.7TotalLevel 0.57 mmol/lSD = 0.011CV(%) = 1.9Level 1.83 mmol/lSD = 0.024CV(%) = 1.3
Method Comparison	(Unit mmol/l)(Deming):y=0.98x-0.01r = 0.999Range 0.25 - 4.09 mmol/lN = 117	A comparison of this Lithiummethod (Method 1) vs NOVA ISE(Method 2) was run onAU600/AU640r = 0.9956y= 1.01x-0.007Range 0.11 - 1.73 mmol/lN = 55 serum samples
Lithium
Attribute	New device #1Lithium Micro Volume ElectrodeCalibrator partISE Calibrator 1 and ISECalibrator 2 & 3	Predicate device #1Infinity™ Lithium Reagent forOlympus® (K003583)Thermo Trace TR66002Calibrator partLithium Standard TR66901
Limitations	Bilirubin (conjugated):No interference foundup to 41 mg/dl (700 µmol/l) ofconjugated Bilirubin	Free Bilirubin:No significant interference from freebilirubin (<10% deviation) up to 769µmol/l (45 mg/dl)
	Lipemia:No interference found up to 1000mg/dl (10 g/l) of Intralipid®Hemolysate:No interference found up to 1000mg/dl (10 g/l) of hemoglobin.	Conjugated Bilirubin:No significant interference fromconjugated bilirubin (<10%deviation) up to 769 µmol/l (45mg/dl)Lipemia:No significant interference fromlipemia (<10% deviation) measuredas triglycerides, up to 22.6 mmol/l(2000 mg/dl)Hemoglobin: No interference fromhemoglobin (<5% deviation) up to2 g/lNo significant interference (<5%deviation from assigned lithiumconcentration) fromSodium:Up to 200 mmol/lPotassium:Up to 8.00 mmol/lCalcium:Up to 4.00 mmol/l (16 mg/dl)Magnesium:Up to 2.00 mmol/l (4.86 mg/dl)Iron:Up to 200µmol/l (1117 µg/dl)Zinc:Up to 250 µmol/l (1625 µg/dl)Copper:Up to 250 µmol/l (1588 µg/dl)

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Table 1 Lithium

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The following table compares the Theophylline with the predicate assay

Table 2 Theophylline

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Theophylline
Attribute	New device #2	Predicate device #2(K961462)
Intended Use	For in vitro diagnostic use in thequantitative determination of thetheophylline concentration in humanserum on T60 analyzer.Measurements are used in thediagnosis and treatment oftheophylline overdose and inmonitoring levels of theophylline tohelp ensure proper therapy	The CEDIA® Theophylline IIhomogeneous enzyme immunoassayis for the quantitation oftheophylline in human serum orplasma using automated clinicalchemistry analyzers. Measurementsare used in the diagnosis andtreatment of theophylline overdoseand in monitoring levels oftheophylline to ensure propertherapy.
Indication for Use	Theophylline is intended forquantitative in vitro diagnosticdetermination of the theophyllineconcentration in human serum usingT60 Clinical Chemistry Analyzers.Measurements are used in thediagnosis and treatment oftheophylline overdose and inmonitoring levels of theophylline tohelp ensure proper therapy.	The CEDIA® Theophylline IIhomogeneous enzyme immunoassayis for the quantitation oftheophylline in human serum orplasma using automated clinicalchemistry analyzers. Measurementsare used in the diagnosis andtreatment of theophylline overdoseand in monitoring levels oftheophylline to ensure propertherapy.
Assay Protocol	Assay uses recombinant DNAtechnology (US Patent no. 4708929)to produce a unique homogeneousenzyme immunoassay system.	Assay uses recombinant DNAtechnology (US Patent no. 4708929)to produce a unique homogeneousenzyme immunoassay system.
Traceability/Standardization	The calibration values are traceableto USP reference materials preparedgravimetrically to drug-free humanserum.	-
Sample Type	Serum	Serum or plasma (Na or Li heparin,Na EDTA)
Reagent Storage	The unopened reagents are stable at2...8 °C until the expiration datestated on the label. Refer to theApplication Notes of your T60analyzer for the on board stability ofreagents.DO NOT FREEZE the unopenedreagents or the reconstitutedreagents.	Store CEDIA® Theophylline IIreagents at 2-8 °C. Do not freeze.For stability of the unopenedcomponents refer to the box orbottle labels for the expiration date
Theophylline
Attribute	New device #2	Predicate device #2(K961462)
Expected Values	Therapeutic rangeAccording to different sources thesuggested ranges are:8 - 20 µg/ml or 44 - 111 µmol/l(Asthma) (1,2)10 - 20 µg/ml or 56 - 111 µmol/l(Asthma) (3)5 - 10 µg/ml or 28 - 56 µmol/l(Apnea) (1)	Therapeutic range:10 - 20 µg/ml in adults (asthma)5 -10 µg/ml in newborns (apnea)
Instrument	T60 and DPC T60i, DPC T60i Kusti	Roche Hitachi 911/917
Measuring Range	From 1.4 µg/ml or 7.8 µmol/l to 40µg/ml or 222 µmol/l.	Between 0.8 µg/ml and the value ofthe Core TDM Multi-Cal HighCalibrator (approximately 40 µg/mlor 222 µmol/l)
Precision	Within runLevel 4.4 µg/mlSD = 0.17CV(%) = 3.9Level 13.8 µg/mlSD = 0.21CV(%) = 1.5Level 28.1 µg/mlSD = 0.21CV(%) = 0.8Between runLevel 4.4 µg/mlSD = 0.10CV(%) = 2.2Level 13.8 µg/mlSD = 0.18CV(%) = 1.3Level 28.1 µg/mlSD = 0.31CV(%) = 1.1TotalLevel 4.4 µg/mlSD = 0.35CV(%) = 8.0Level 13.8 µg/mlSD = 0.59CV(%) = 4.3Level 28.1 µg/mlSD = 0.87CV(%) = 3.1	Within runLevel 5.1 µg/mlSD = 0.17CV(%) = 3.3Level 15.1 µg/mlSD = 0.28CV(%) = 1.9Level 29.3 µg/mlSD = 0.39CV(%) = 1.3TotalLevel 5.1 µg/mlSD = 0.26CV(%) = 5.1Level 15.1 µg/mlSD = 0.36CV(%) = 2.4Level 29.3 µg/mlSD = 0.59CV(%) = 2.0
Theophylline
Attribute	New device #2	Predicate device #2(K961462)
Method Comparison	(Unit µg/ml)(Deming):$y = 0.989x + 0.05$$r = 0.998$Range 1.1 - 37.7 µg/mlN = 133	Commercially availablefluorescence polarizationimmunoassay (x).Correlation (µg/ml) (Deming's):$y=1.01x -0.41$$r = 0.997$$Sy.x = 0.47$Range 0.9 - 37.4 µg/mlN = 125
Limitations	No interference foundBilirubin:up to 58 mg/dl (1000 µmol/l)Hemoglobin:up to 1000 mg/dl (10 g/l)Lipemia:up to 1000 mg/dl (10 g/l) ofIntralipid®Due to cross-reactivity with 1,3-Dimethyluric Acid, the Theophyllineassay should not be used to quantitatesamples from uremic patients.	Ikterus:No significant interference frombilirubin up to 66 mg/dl)Hemolysis:No significant interference fromhemoglobin up to 1000 mg/dl)Lipemia (Intralipid®):No significant interference fromlipemia up to an L index of 1000(approximate triglycerideconcentration: 2000 mg/dl).No significant interference fromtotal protein up to 12 g/dl.No significant interference fromrheumatoid factor up to 180 IU/ml.Due to cross-reactivity with 1,3-Dimethyluric Acid, the Theophyllineassay should not be used to quantitatesamples from uremic patients.

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S C I E N T I F I C

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Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three legs and a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. The eagle is black, and the text is in a simple, sans-serif font.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT - 9 2007

Thermo Fisher Scientific Oy c/o Ms. Päivi Sormunen Vice President of Industrial Solutions & QRC Ratastie 2 P.O. Box 100 Vantaa, Finland FIN-01621

Re: K063705

Trade/Device Name: Lithium Micro Volume Electrode, Theophylline, ISE Calibrator 1, ISE Calibrator 2&3, TDM Calibration set B Regulation Number: 21 CFR 862.3560 Regulation Name: Lithium Test System Regulatory Class: Class II Product Code: NDW, KLS, JIX, DKB Dated: September 25, 2007 Received: September 27, 2007

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 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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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

K063705 510(k) Number :

Device Names: Lithium Micro Volume Electrode Theophylline ISE Calibrator 1 ISE Calibrator 2 & 3 TDM Calibration set B

Indications for Use:

TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981649 Theophylline assay on T60 Analyzer.

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 (OIVD)

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

510(k) K063705

Regulation Number and Section

§ 862.3560 Lithium test system.

(a)
Identification. A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).(b)
Classification. Class II.