(300 days)
Not Found
No
The summary describes standard in vitro diagnostic assays and calibrators for clinical chemistry analyzers, with performance metrics based on method comparison and precision studies. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No
Explanation: This device is for in vitro diagnostic use, meaning it's used to analyze samples outside of the body for diagnostic purposes, not to directly treat a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "Lithium is intended for in vitro diagnostic use" and "Theophylline is intended for quantitative in vitro diagnostic determination". Additionally, it mentions "Measurements are used as an aid in the management of individuals taking lithium" and "Measurements are used in the diagnosis and treatment of theophylline overdose." These phrases directly indicate its use in diagnosing and managing conditions.
No
The device is described as an in vitro diagnostic (IVD) reagent kit for use on a clinical chemistry analyzer (T60). This indicates it is a physical product (reagents and calibrators) used in conjunction with hardware (the analyzer), not a standalone software device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states for both Lithium and Theophylline assays, as well as the ISE Calibrators and TDM Calibration set B, that they are "intended for in vitro diagnostic use". This is the defining characteristic of an IVD.
N/A
Intended Use / Indications for 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.
Indications for Use:
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.
Product codes (comma separated list FDA assigned to the subject device)
NDW, KLS, JIX, DKB
Device Description
Not Found
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Lithium
Precision:
- Within run:
- Level 0.95 mmol/l: SD = 0.008, CV(%) = 0.9
- Level 1.86 mmol/l: SD = 0.017, CV(%) = 0.9
- Between run:
- Level 0.95 mmol/l: SD = 0.009, CV(%) = 0.9
- Level 1.86 mmol/l: SD = 0.009, CV(%) = 0.5
- Total:
- Level 0.95 mmol/l: SD = 0.020, CV(%) = 2.1
- Level 1.86 mmol/l: SD = 0.039, CV(%) = 2.1
Method Comparison:
(Unit mmol/l) (Deming): y=0.98x-0.01, r = 0.999, Range 0.25 - 4.09 mmol/l, N = 117
Limitations:
- Bilirubin (conjugated): No interference found up to 41 mg/dl (700 µmol/l) of conjugated Bilirubin
- Lipemia: No interference found up to 1000 mg/dl (10 g/l) of Intralipid®
- Hemolysate: No interference found up to 1000 mg/dl (10 g/l) of hemoglobin.
Theophylline
Precision:
- Within run:
- 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
- Between run:
- Level 4.4 µg/ml: SD = 0.10, CV(%) = 2.2
- Level 13.8 µg/ml: SD = 0.18, CV(%) = 1.3
- Level 28.1 µg/ml: SD = 0.31, CV(%) = 1.1
- Total:
- 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:
(Unit µg/ml) (Deming): y = 0.989x + 0.05, r = 0.998, Range 1.1 - 37.7 µg/ml, N = 133
Limitations:
- Bilirubin: No interference found up to 58 mg/dl (1000 µmol/l)
- Hemoglobin: No interference found up to 1000 mg/dl (10 g/l)
- Lipemia: No interference found up to 1000 mg/dl (10 g/l) of Intralipid®
- Cross-reactivity: Due to cross-reactivity with 1,3-Dimethyluric Acid, the Theophylline assay should not be used to quantitate samples from uremic patients.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 2 |
| P.O. Box 100 | |
| FIN-01621 Vantaa | |
| Finland | |
| 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
1
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.
2
E. Indications for use
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.
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
3
The following table compares the Lithium with the predicate assay H.
| Table 1 Lithium | ||
|---|---|---|
| Attribute | New device #1 | |
| Lithium Micro Volume Electrode | ||
| Calibrator part | ||
| ISE Calibrator 1 and ISE | ||
| Calibrator 2 & 3 | Predicate device #1 | |
| Infinity™ Lithium Reagent for | ||
| Olympus® (K003583) | ||
| Thermo Trace TR66002 | ||
| Calibrator part | ||
| Lithium Standard TR66901 | ||
| Intended Use | For in vitro diagnostic use in the | |
| quantitative determination of the | ||
| lithium concentration in human | ||
| serum on T60 analyzer. | Reagent for the quantitative | |
| determination of Lithium | ||
| concentration in human serum and | ||
| plasma on the Olympus | ||
| AU400/AU600/AU640/AU2700/ | ||
| AU5400 chemistry analysers. | ||
| Indication for Use | 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). | Lithium is widely used in the | |
| treatment of manic depressive | ||
| psychosis. | ||
| Assay Protocol | Potentiometric | Spectrophotometric |
| Traceability/ | ||
| Standardization | NIST SRM 924 | - |
| Sample Type | Serum | Serum or EDTA-plasma |
| Reagent Storage | Calibrators in unopened bags or vials | |
| are stable at 2...30 °C until the | ||
| expiration date printed on the label. |
Electrodes have to be stored at
2...8 °C before installation. | The unopened reagents are stable
until the expiration date when stored
at 2-8°C. |
| Expected Values | Therapeutic range
According to source (1) suggested
range is:
0.6 - 1.2 mmol/l
Concentrations of 1.2 to 1.5 mmol/l
signify a warning range and
concentrations over 1.5 mmol/l
indicate a significant risk of
intoxication. | 12 hour post dose trough
concentration: 1.0 - 1.2 mmol/l
Values >1.5 mmol/l 12 hours after
dose indicates a significant risk of
intoxication. |
| Lithium | | |
| Attribute | New device #1
Lithium Micro Volume Electrode
Calibrator part
ISE Calibrator 1 and ISE
Calibrator 2 & 3 | Predicate device #1
Infinity™ Lithium Reagent for
Olympus® (K003583)
Thermo Trace TR66002
Calibrator part
Lithium 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 run
Level 0.95 mmol/l
SD = 0.008
CV(%) = 0.9
Level 1.86 mmol/l
SD = 0.017
CV(%) = 0.9
Between run
Level 0.95 mmol/l
SD = 0.009
CV(%) = 0.9
Level 1.86 mmol/l
SD = 0.009
CV(%) = 0.5
Total
Level 0.95 mmol/l
SD = 0.020
CV(%) = 2.1
Level 1.86 mmol/l
SD = 0.039
CV(%) = 2.1 | Within run
Level 0.57 mmol/l
SD = 0.005
CV(%) = 0.9
Level 1.83 mmol/l
SD = 0.012
CV(%) = 0.7
Total
Level 0.57 mmol/l
SD = 0.011
CV(%) = 1.9
Level 1.83 mmol/l
SD = 0.024
CV(%) = 1.3 |
| Method Comparison | (Unit mmol/l)
(Deming):
y=0.98x-0.01
r = 0.999
Range 0.25 - 4.09 mmol/l
N = 117 | A comparison of this Lithium
method (Method 1) vs NOVA ISE
(Method 2) was run on
AU600/AU640
r = 0.9956
y= 1.01x-0.007
Range 0.11 - 1.73 mmol/l
N = 55 serum samples |
| Lithium | | |
| Attribute | New device #1
Lithium Micro Volume Electrode
Calibrator part
ISE Calibrator 1 and ISE
Calibrator 2 & 3 | Predicate device #1
Infinity™ Lithium Reagent for
Olympus® (K003583)
Thermo Trace TR66002
Calibrator part
Lithium Standard TR66901 |
| Limitations | Bilirubin (conjugated):
No interference found
up to 41 mg/dl (700 µmol/l) of
conjugated Bilirubin | Free Bilirubin:
No significant interference from free
bilirubin (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 | The CEDIA® Theophylline II
homogeneous enzyme immunoassay
is for the quantitation of
theophylline in human serum or
plasma using automated clinical
chemistry analyzers. Measurements
are used in the diagnosis and
treatment of theophylline overdose
and in monitoring levels of
theophylline to ensure proper
therapy. |
| Indication for Use | 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 CEDIA® Theophylline II
homogeneous enzyme immunoassay
is for the quantitation of
theophylline in human serum or
plasma using automated clinical
chemistry analyzers. Measurements
are used in the diagnosis and
treatment of theophylline overdose
and in monitoring levels of
theophylline to ensure proper
therapy. |
| Assay Protocol | Assay uses recombinant DNA
technology (US Patent no. 4708929)
to produce a unique homogeneous
enzyme immunoassay system. | Assay uses recombinant DNA
technology (US Patent no. 4708929)
to produce a unique homogeneous
enzyme immunoassay system. |
| Traceability/
Standardization | The calibration values are traceable
to USP reference materials prepared
gravimetrically to drug-free human
serum. | - |
| Sample Type | Serum | Serum or plasma (Na or Li heparin,
Na EDTA) |
| Reagent Storage | The unopened reagents are stable at
2...8 °C until the expiration date
stated on the label. Refer to the
Application Notes of your T60
analyzer for the on board stability of
reagents.
DO NOT FREEZE the unopened
reagents or the reconstituted
reagents. | Store CEDIA® Theophylline II
reagents at 2-8 °C. Do not freeze.
For stability of the unopened
components refer to the box or
bottle labels for the expiration date |
| Theophylline | | |
| Attribute | New device #2 | Predicate device #2
(K961462) |
| Expected Values | Therapeutic range
According to different sources the
suggested 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 40
µg/ml or 222 µmol/l. | Between 0.8 µg/ml and the value of
the Core TDM Multi-Cal High
Calibrator (approximately 40 µg/ml
or 222 µmol/l) |
| Precision | Within run
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
Between run
Level 4.4 µg/ml
SD = 0.10
CV(%) = 2.2
Level 13.8 µg/ml
SD = 0.18
CV(%) = 1.3
Level 28.1 µg/ml
SD = 0.31
CV(%) = 1.1
Total
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 | Within run
Level 5.1 µg/ml
SD = 0.17
CV(%) = 3.3
Level 15.1 µg/ml
SD = 0.28
CV(%) = 1.9
Level 29.3 µg/ml
SD = 0.39
CV(%) = 1.3
Total
Level 5.1 µg/ml
SD = 0.26
CV(%) = 5.1
Level 15.1 µg/ml
SD = 0.36
CV(%) = 2.4
Level 29.3 µg/ml
SD = 0.59
CV(%) = 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/ml
N = 133 | Commercially available
fluorescence polarization
immunoassay (x).
Correlation (µg/ml) (Deming's):
$y=1.01x -0.41$
$r = 0.997$
$Sy.x = 0.47$
Range 0.9 - 37.4 µg/ml
N = 125 |
| Limitations | No interference found
Bilirubin:
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) of
Intralipid®
Due to cross-reactivity with 1,3-
Dimethyluric Acid, the Theophylline
assay should not be used to quantitate
samples from uremic patients. | Ikterus:
No significant interference from
bilirubin up to 66 mg/dl)
Hemolysis:
No significant interference from
hemoglobin up to 1000 mg/dl)
Lipemia (Intralipid®):
No significant interference from
lipemia up to an L index of 1000
(approximate triglyceride
concentration: 2000 mg/dl).
No significant interference from
total protein up to 12 g/dl.
No significant interference from
rheumatoid factor up to 180 IU/ml.
Due to cross-reactivity with 1,3-
Dimethyluric Acid, the Theophylline
assay should not be used to quantitate
samples from uremic patients. |
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
7
ThermoFisher
S C I E N T I F I C
・・・・・・・・・・・・
- . . . . . -
.
- --- .--
ﻤ
,并且一次,
8
ThermoFisher
S C I E N T I F I C
9
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).
10
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
11
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:
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.
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