K Number

Device Name

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

Manufacturer

THERMO ELECTRON OY

Date Cleared

2007-10-05

(357 days)

Product Code

KLT DKB LEG

Regulation Number

862.3645

Intended 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.

Device Description

Not Found

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

CEDIA® Carbamazepine II, CEDIA® Valproic acid II

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in vitro diagnostic assay for measuring drug concentrations using a clinical chemistry analyzer. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on traditional analytical metrics like precision and method comparison.

Therapeutic

The device is an in vitro diagnostic intended for quantitative determination of drug concentrations, which helps in diagnosis and monitoring, but does not directly provide therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the quantitative in vitro diagnostic determination" of drug concentrations and that "Measurements are used in the diagnosis and treatment" of overdose and for monitoring therapy.

SaMD (Software as a Medical Device)

The device is an in vitro diagnostic (IVD) assay kit intended for use on a clinical chemistry analyzer (T60). It involves the quantitative determination of substances in human serum, which is a chemical process, not a software-only function.

IVD (In Vitro Diagnostic)

Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The document explicitly states that the Carbamazepine and Valproic Acid assays are "intended for the quantitative in vitro diagnostic determination" of these substances in human serum. It also mentions their use in "diagnosis and treatment" and "monitoring levels," which are typical applications for IVDs.
TDM Calibration set B: This component is also described as being "intended for in vitro diagnostic use as a calibrator."

The core function of these devices is to analyze biological samples (human serum) outside of the body to provide information for diagnostic and treatment purposes. This aligns perfectly with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

KLT, LEG, DKB

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human serum

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)

Carbamazepine

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)
Method Comparison:
- Deming: y = 0.98 x + 0.02
- r = 0.993
- Range 1.9 - 19.6 µg/ml
- N = 134
Limitations: No interference found with 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®.

Valproic Acid

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)
Method Comparison:
- Deming: y = 0.996 x + 1.4
- r = 0.993
- Range 3.2 - 143.4 µg/ml
- N = 136
Limitations: No interference found with 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®.

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.

CEDIA® Carbamazepine II, CEDIA® Valproic acid II

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

Regulation Number and Section

§ 862.3645 Neuroleptic drugs radioreceptor assay test system.

(a)
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.(b)
Classification. Class II.

Summary

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

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

Valproic Acid

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.

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 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

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

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

SCIENTIFIC

Thermo Fisher Scientific Oy

Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki

www.thermo com

Predicate Test System	Valproic Acid
$\frac{d[Drug]}{dt} = k_{in} - k_{out}*[Drug]$	$\frac{d[Drug]}{dt} = k_{in} - k_{out}[Drug] - k_{met}[Drug]$

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

S C

+358 (9) 329 100 tel
+358 (9) 3291 0500 fax

u www.thermo com

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).

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

Indications for Use

510(k) Number (if known): K063131

Device Names: Carbamazepine Valproic Acid TDM Calibration set B

Indications for Use:

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|