What is the regulatory pathway for CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS?

Cedia Carbamazepine II (k914857); Cedia Valproic Acid II (k930734); Cedia DAU 5-Drug Calibrators (k935792).

Who can help prepare an FDA 510(k) submission like CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS

Q: Who is the manufacturer of CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS?

Thermo Electron OY filed the 510(k) submission for CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS (K063131).

Q: What is the FDA product code for CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS?

KLT. It is classified under 21 CFR 862.3645 as a Class 2 device in the Clinical Toxicology panel.

K063131 · Thermo Electron OY · KLT · Oct 5, 2007 · Clinical Toxicology

Device Facts

Record ID	K063131
Device Name	CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
Applicant	Thermo Electron OY
Product Code	KLT · Clinical Toxicology
Decision Date	Oct 5, 2007
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3645
Device Class	Class 2

Intended Use

For in vitro diagnostic use in the quantitative determination of the carbamazepine concentration in human serum on T60 analyzer. Measurements are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to help ensure proper therapy. For in vitro diagnostic use in the quantitative determination of the valproic acid concentration in human serum on T60 instrument. Measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to help ensure proper therapy. For in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981645 Carbamazepine and kit code 981650 Valproic acid assays on T60 Analyzer.

Device Story

The Carbamazepine and Valproic Acid test systems are in vitro diagnostic assays designed for use on T60 Clinical Chemistry Analyzers. The device utilizes a homogeneous enzyme immunoassay system based on recombinant DNA technology (US Patent 4708929). The system processes human serum samples to quantitatively measure drug concentrations. The output is a concentration value (µg/ml) provided to clinicians to assist in the diagnosis and treatment of drug overdose and to monitor therapeutic levels to ensure proper patient management. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Performance was established through bench testing and method comparison studies. Precision was evaluated with total CVs ranging from 2.8% to 6.3% for Carbamazepine and 2.7% to 5.4% for Valproic Acid. Method comparison against predicate devices showed strong correlation (r=0.993 for both assays) with N=134 and N=136 respectively. Interference testing confirmed accuracy in the presence of hemoglobin, bilirubin, and lipemia up to specified concentrations.

Technological Characteristics

Homogenous enzyme immunoassay; bacterial beta-galactosidase fragments; spectrophotometric detection. Reagents include MOPS/MES/HEPES buffers, mouse monoclonal antibodies, enzyme donor/acceptor conjugates, and sodium azide. Storage 2-8°C. Analyzed on T60 Clinical Chemistry Analyzers. Calibrators are ready-to-use liquid, traceable to USP reference materials.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of carbamazepine or valproic acid concentrations in human serum using T60 Clinical Chemistry Analyzers. Used for diagnosis/treatment of drug overdose and therapeutic drug monitoring. No specific age or gender contraindications provided.

Regulatory Classification

Identification

A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

Predicate Devices

Cedia Carbamazepine II (k914857)
Cedia Valproic Acid II (k930734)
Cedia DAU 5-Drug Calibrators (k935792)

Related Devices

K063145 — PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS · Thermo Electron OY · Oct 17, 2007
K964442 — VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM · Bayer Corp. · Dec 18, 1996
K042476 — VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS · Ortho-Clinical Diagnostics, Inc. · Dec 1, 2004
K042807 — ADVIA IMS VALPROIC ACID METHOD · Bayer Healthcare, LLC · Feb 8, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo for Thermo Fisher Scientific. The logo is composed of two lines of text. The first line is the company name, "ThermoFisher", in a bold, sans-serif font. The second line is the word "SCIENTIFIC" in a smaller, sans-serif font. 0CT 5 " 2007 ## 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: k063131 ### Introduction: A. 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 Thermo Fisher Scientific Oy Ratastie 2 P.O. Box 100 FIN-01621 Vantaa Finland +358 (9) 329 100 tel +358 (9) 3291 0500 fax Contact: Päivi Sormunen, Vice President of QRC Date of Preparation: September 25, 2007 #### C. Device name Proprietary name: Carbamazepine Common name: Carbamazepine test system Classification: II Class: Toxicology Product Code: KLT Proprietary name: Valproic Acid Common name: Valproic Acid test system Classification: II Class: Toxicology Product Code: LEG Proprietary name: TDM Calibration set B Common name: Calibrator Classification: II Class: Toxicology Product Code: DKB Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Thermo Fisher Scientific. The words "Thermo Fisher" are in bold, and the word "SCIENTIFIC" is in a smaller font size below. The logo is black and white. ### D. Intended Use ## Carbamazepine For in vitro diagnostic use in the quantitative determination of the carbamazepine concentration in human serum on T60 analyzer. Measurements are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to help ensure proper therapy. ## Valproic Acid For in vitro diagnostic use in the quantitative determination of the valproic acid concentration in human serum on T60 instrument. Measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to help ensure proper therapy. ### TDM Calibration set B For in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981645 Carbamazepine and kit code 981650 Valproic acid assays on T60 Analyzer. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Thermo Fisher Scientific. The words "Thermo Fisher" are on the top line in a bold, sans-serif font. The word "SCIENTIFIC" is on the second line, in a smaller, sans-serif font. ### E. Indications for use The Carbamazepine is intended for the quantitative in vitro diagnostic determination of the carbamazepine concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to help ensure proper therapy. The Valproic Acid is intended for the quantitative in vitro diagnostic determination of the valproic acid concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to help ensure proper therapy. TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981645 Carbamazepine and kit code 981650 Valproic acid assays on T60 Analyzer. ### F. Substantial Equivalence CEDIA® Carbamazepine II Microgenics Corporation CEDIA® Valproic acid II Microgenics Corporation ### Substantial equivalence -similarities G. T60 Carbamazepine and Valproic Acid are substantially equivalent to other devices legally marketed in United Staes. We claim equivalence to the Microgenics Corporation CEDIA® Carbamazepine II and CEDIA® Valproic acid II Y -tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki {3}------------------------------------------------ | Attribute | New device #1 | Predicate device #1 | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | For in vitro diagnostic use in the quantitative determination of the carbamazepine concentration in human serum on T60 analyzer. Measurements are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to help ensure proper therapy. | The CEDIA® Carbamazepine II homogeneous enzyme immunoassay is for the quantitation of carbamazepine in human serum or plasma using automated clinical chemistry analyzers. Measurements are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure proper therapy. | | Indication for Use | The Carbamazepine is intended for the quantitative in vitro diagnostic determination of the carbamazepine concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to help ensure proper therapy. | See Intended Use | | Assay Protocol | Assay uses recombinant DNA technology (US Patent no. 4708929) to produce a unique homogenous enzyme immunoassay system. | Assay uses recombinant DNA technology (US Patent no. 4708929) to produce a unique homogenous enzyme immunoassay system. | | Traceability/Standardiza tion | The calibration values are traceable to USP reference materials prepared gravimetrically to drug-free human serum. | The calibration values are traceable to USP reference materials prepared gravimetrically to drug-free human serum. | | Sample Type | Human 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 Carbamazepine 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 | | | | The following table compares the Carbamazepine with the predicate test system | | | |--|--|-------------------------------------------------------------------------------|--|--| | | | | | | {4}------------------------------------------------ # t | Attribute | New device #1 | Predicate device #1 | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Expected Values | Therapeutic range for adults: According to different sources the suggested ranges are: 4 - 12 µg/ml or 17 - 51 µmol/l (1) 4 - 10 µg/ml or 17 - 42 µmol/l (2) | Therapeutic Range (µg/ml) Penry and Newmark 5-12 Scheuer and Pedley 8-12 Troupin et al 8-12 Strandjord and Johannessen 3-12 Simonsen et al 6-10 Larkin et al 4-10 Shorvon et al 4-8 MacKichan and Kutt 4-12 | | Instrument | T60, DPC T60i, and DPC T60i Kusti | Roche Hitachi 911/912 | | Measuring Range | From 1.0 µg/ml to 19.0 µg/ml. | Between 0.5 µg/ml and the value of the Core TDM Multi-Cal High Calibrator (approximately 20 µg/ml or 84.6 µmol/l). | | Precision | Within run Level 3.0 µg/ml SD = 0.09 CV(%) = 2.8 Level 9.5 µg/ml SD = 0.14 CV(%) = 1.5 Level 15.0 µg/ml SD = 0.16 CV(%) = 1.1 Between run Level 3.0 µg/ml SD = 0.07 CV(%) = 2.4 Level 9.5 µg/ml SD = - CV(%) = - Level 15.0 µg/ml SD = 0.14 CV(%) = 0.9 Total Level 3.0 µg/ml SD = 0.19 CV(%) = 6.3 Level 9.5 µg/ml SD = 0.32 CV(%) = 3.3 Level 15.0 µg/ml SD = 0.42 CV(%) = 2.8 | Within run Level 4.2 µg/ml SD = 0.06 CV(%) = 1.5 Level 10.6 µg/ml SD = 0.08 CV(%) = 0.8 Level 16.8 µg/ml SD = 0.12 CV(%) = 0.7 Total Level 4.2 µg/ml SD = 0.15 CV(%) = 3.5 Level 10.6 µg/ml SD = 0.21 CV(%) = 2.0 Level 16.8 µg/ml SD = 0.29 CV(%) = 1.7 | | Attribute | New device #1 | Predicate device #1 | | Method Comparison | (Unit µg/ml) Deming: $y = 0.98 x + 0.02$ $r = 0.993$ Range 1.9 - 19.6 µg/ml N = 134 | Previous CEDIA Carbamazepine assay (x). Correlation (µg/ml) (Deming's): $Y =1.04x -0.04$ $r = 0.999$ Sy.x = 0.26 Range 1.3 - 19.8 µg/ml N = 103 | | Limitations | No interference found Hemoglobin: up to 1000 mg/dl (10 g/l). Bilirubin: up to 58 mg/dl (1000 µmol/l) Lipemia: up to 1000 mg/dl (10 g/l) of Intralipid® | Samples containing carbamazepine and the following concentrations of potential interference substances were quantitated accurately by the CEDIA® Carbamazepine II assay: Hemoglobin up to 1000 mg/dl, Bilirubin up to 66 mg/dl, Triglyceride up to 1000 mg/dl, Total protein up to 12 g/dl, Rheumatoid factor up to 180 IU/ml | | Attribute | New device #1 | Predicate device #1 | | Intended Use | For in vitro diagnostic use in the quantitative determination of the valproic acid concentration in human serum on T60 instrument. Measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to help ensure proper therapy. | The CEDIA® Valproic Acid II homogeneous enzyme immunoassay is for the quantitation of valproic acid in human serum or plasma using automated clinical chemistry analyzers. Measurements are used as an aid in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure proper therapy. | | Indication for Use | The Valproic Acid is intended for the quantitative in vitro diagnostic determination of the valproic acid concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to help ensure proper therapy. | See Intended Use | | Assay Protocol | Assay uses recombinant DNA technology (US Patent no. 4708929) to produce a unique homogenous enzyme immunoassay system. | Assay uses recombinant DNA technology (US Patent no. 4708929) to produce a unique homogenous enzyme immunoassay system. | | Traceability/Standardiza tion | The calibration values are traceable to USP reference materials prepared gravimetrically to drug-free human serum. | The calibration values are traceable to USP reference materials prepared gravimetrically to drug-free human serum. | | Sample Type | Human 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. DO NOT FREEZE the unopened reagents or the reconstituted reagents. | Store CEDIA® Valproic acid 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 | 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.thermo.com {5}------------------------------------------------ SCIENTIFIC Thermo Fisher Scientific Oy Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki www.thermo com {6}------------------------------------------------ | Predicate Test System | Valproic Acid | |------------------------------------------------|-----------------------------------------------------------------| | $\frac{d[Drug]}{dt} = k_{in} - k_{out}*[Drug]$ | $\frac{d[Drug]}{dt} = k_{in} - k_{out}*[Drug] - k_{met}*[Drug]$ | {7}------------------------------------------------ ਪ | Attribute | New device #1 | Predicate device #1 | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Expected Values | Therapeutic range for adults: 50 - 100 µg/ml or 347 - 693 µmol/l (1,2) | Therapeutic Schobben et al 50-100 µg/ml Cloyd and Leppik 50-100 µg/ml Klotz and Schweizer 40-90 µg/ml Turnbull et al 50-100 µg/ml Toxic Schobben et al - µg/ml Cloyd and Leppik >100 µg/ml Klotz and Schweizer - Turnbull et al >100 µg/ml | | Instrument | T60, DPC T60i, and DPC T60i Kusti | Roche Hitachi 911/912 | | Measuring Range | From 3.0 µg/ml to 142.5 µg/ml. | Between 3.0 µg/ml and the value of the Core TDM High Calibrator (approximately 150 µg/ml or 1039.5 µmol/l) | | Precision | Within run Level 35.0 µg/ml SD = 0.43 CV(%) = 1.2 Level 81.1 µg/ml SD = 0.81 CV(%) = 1.0 Level 113.6 µg/ml SD = 1.01 CV(%) = 0.9 Between run Level 35.0 µg/ml SD = 0.61 CV(%) = 1.8 Level 81.1 µg/ml SD = 1.08 CV(%) = 1.3 Level 113.6 µg/ml SD = 1.07 CV(%) = 0.9 Total Level 35.0 µg/ml SD = 1.90 CV(%) = 5.4 Level 81.1 µg/ml SD = 3.15 CV(%) = 3.9 Level 113.6 µg/ml SD = 3.11 CV(%) = 2.7 | Within run Level 24.4 µg/ml SD = 0.59 CV(%) = 2.4 Level 95.0 µg/ml SD = 1.43 CV(%) = 1.5 Level 136.8 µg/ml SD = 1.81 CV(%) = 1.3 Total Level 24.4 µg/ml SD(µg/ml) = 0.83 CV(%) = 3.4 Level 95.0 µg/ml SD = 1.93 CV(%) = 2.0 Level 136.8 µg/ml SD = 2.48 CV(%) = 1.8 | | Attribute | New device #1 | Predicate device #1 | | Method Comparison | (Unit µg/ml) Deming: $y = 0.996 x + 1.4$ $r = 0.993$ Range 3.2 - 143.4 µg/ml N = 136 | Commercially available fluorescence polarization immunoassay (x) Correlation (µg/ml) (Linear regression): $Y = 1.08x -0.61$ $r = 0.972$ $Sy.x = 7.042$ Range 2.6 - 119.8 µg/ml N = 77 | | Limitations | No interference found Hemoglobin: up to 1000 mg/dl (10 g/l). Bilirubin: up to 58 mg/dl (1000 µmol/l) Lipemia: up to 1000 mg/dl (10 g/l) of Intralipid® | Samples containing valproic acid and the following concentrations of potential interference substances were quantitated accurately by the CEDIA Valproic Acid II assay: Hemoglobin up to 1000 mg/dl, Bilirubin up to 60 mg/dl, Triglyceride up to 1000 mg/dl, Total protein up to 10 g/dl, IgA up to 790 mg/dl IgG up to 4300 mg/dl, IgM up to 840 mg/dl and Rheumatoid factor up to 200 IU/ml | Thermo Fisher Scientific Oy Ratastie 2 P.O. Box 100 FIN-01621 Vantaa Finland +358 (9) 329 100 tcl +358 (9) 3291 0500 fax Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki www.thermo.com {8}------------------------------------------------ S C +358 (9) 329 100 tel +358 (9) 3291 0500 fax u www.thermo com {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows a circular logo with an eagle in the center. The eagle is stylized with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. The logo appears to be a seal or emblem, possibly representing a government agency. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Thermo Fisher Scientific Oy c/o Mr. Päivi Sormunen Vice President of ORC Ratastie 2, P.O. Box 100 FIN-01621 Vantaa, Finland OCT 5 2007 Re: k063131 Trade Name: Carbamazepine, Valproic Acid and TDM Calibration set B Regulation Number: 21 CFR 862.3645 Regulation Name: Neuroleptic drugs radioreceptor assay test system. Regulatory Class: Class II Product Code: KLT, LEG, DKB Dated: September 25, 2007 Received: September 27, 2007 Dear Mr. 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 yours, Jean M. Coopes, M.S., D.v.M. Jéan 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 510(k) Number (if known): K063131 Device Names: Carbamazepine Valproic Acid TDM Calibration set B ## Indications for Use: The Carbamazepine is intended for the quantitative in vitro diagnostic determination of the carbamazepine concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to help ensure proper therapy The Valproic Acid is intended for the quantitative in vitro diagnostic determination of the valproic acid concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to help ensure proper therapy. TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981645 Carbamazepine and kit code 981650 Valproic acid assays on T60 Analyzer. Prescription Use × (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 (OVD) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) # # **Sign-Off** Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety S10(k) |K06313|

CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS

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CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS

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Device Story

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Predicate Devices

Related Devices

Submission Summary (Full Text)

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