The ARK™ Zonisamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of zonisamide in human serum or plasma samples on automated clinical chemistry analyzers. Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide.

The ARK™ Zonisamide Calibrator is intended for use in calibration of the ARK Zonisamide Assay.

The ARK™ Zonisamide Control is intended for use in quality control of the ARK Zonisamide Assav.

Device Description

The ARK Zonisamide Assay is a homogeneous immunoassay based on competition between drug in the specimen and zonisamide labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for binding to the antibody reagent. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly proportional to the drug concentration. Active enzyme converts the coenzyme nicotinamide adenine dinucleotide (NAD) to NADH that is measured spectrophotometrically as a rate of change in absorbance. Endogenous serum G6PDH does not interfere with the results because the coenyzme NAD functions only with the bacterial enzyme used in the assay.

The ARK Zonisamide Assay consists of reagents R1 anti-zonisamide polyclonal antibody with substrate and R2 zonisamide labeled with bacterial G6PDH enzyme. The ARK Zonisamide Calibrator consists of a six-level set to calibrate the assay, and the ARK Zonisamide Control consists of a three-level set used for quality control of the assay.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the ARK Zonisamide Assay, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Test/Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Limit of Quantitation (LOQ)	<20% CV with ±15% recovery	2.0 µg/mL (with corresponding recovery and precision)
Recovery	% Recovery close to 100% (within reasonable analytical limits, e.g., ±15%)	Ranges from 85.3% to 110.0% for concentrations 2.0 - 50.0 µg/mL
Linearity	% Difference ±10% between predicted 1st and 2nd order regressed values (±15% below 3.0 µg/mL)	Ranges from -7.0% to 2.7% for concentrations 2.4 - 48.0 µg/mL
Assay Range	Defined range of quantitative measurement	2.0 to 50.0 µg/mL
Method Comparison (Correlation Coefficient)	High correlation (e.g., r² > 0.90) with predicate device	r² = 0.93 (0.91 to 0.95 95% CI)
Precision (Total CV)	<10% Total CV	Ranges from 4.5% to 5.9% for various concentration levels
Interfering Substances	Error ≤10% in the presence of listed interferents	Error ≤10% for all tested interfering substances
Drug Interference	Error ≤10% in the presence of listed drug compounds	Error ≤10% for all tested drug compounds
Anticoagulants	No significant difference in recovery between serum and plasma	No significant difference between serum and plasma samples
Sample Stability (Room Temp)	Stable for at least 24 hours	Stable for at least 24 hours (22°C)
Sample Stability (Refrigerated)	Stable for a specified duration	Stable for 28 days (2-8°C)
Sample Stability (Frozen)	Stable for a specified duration	Stable for 56 days
Sample Stability (Freeze/Thaw)	Stable after 3 successive freeze/thaw cycles	Stable after 3 successive freeze/thaw cycles
Calibration Curve Stability	Effective for a specified duration	Effective up to 46 days
Reagent On-Board Stability	Effective for a specified duration	Effective up to 32 days (uncapped) and 46 days (capped)

Study Details

Sample sizes used for the test set and the data provenance:
- LOQ: 20 replicates for each sample. Data provenance not specified (likely laboratory-prepared samples).
- Recovery: 20 replicates for each sample. Data provenance not specified (likely laboratory-prepared samples with added drug).
- Linearity: Zonisamide concentrations ranged from 0.8 to 80.0 ug/mL, with dilutions made proportionally. Data provenance not specified (likely laboratory-prepared samples).
- Method Comparison: 176 samples. Data provenance not specified.
- Precision: 160 replicates per control level and human serum level (quadruplicate twice a day for 20 days). Data provenance not specified (likely laboratory-prepared controls and pooled human serum specimens).
- Interfering Substances: Zonisamide levels of approximately 15 and 45 µg/mL, spiked with various interferents. Specific number of samples per interferent not specified, but each was "evaluated." Data provenance not specified (likely laboratory-prepared samples).
- Metabolites: Zonisamide levels of 15 µg/mL and 45 µg/mL, spiked with NAZ (50.0, 10.0 µg/mL) and SMAP (50.0, 10.0 µg/mL). Data provenance not specified (likely laboratory-prepared samples).
- Drug Interference: Zonisamide levels of approximately 15 and 45 µg/mL, spiked with various drug compounds. Specific number of samples per drug not specified, but each was "assayed." Data provenance not specified (likely laboratory-prepared samples).
- Anticoagulants: Not explicitly stated, but "studies were conducted" on serum and plasma. Data provenance not specified.
- Sample Stability: Not explicitly stated, but "serum specimens were shown to be stable" under various conditions. Data provenance not specified.
- On-Board Stability: "Supporting data" cited, but specific sample sizes and provenance not detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No expert ground truth was described for the test set. The ground truth for analytical performance studies (LOQ, recovery, linearity, precision) is typically established by precisely preparing samples with known concentrations. For method comparison, the predicate device serves as the comparative "truth."
Adjudication method for the test set:
- Not applicable, as this is an in vitro diagnostic assay and not an image-based or qualitative diagnostic device requiring expert adjudication.
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 an in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the entire submission describes the standalone performance of the ARK Zonisamide Assay. Its function is to quantitatively determine zonisamide concentrations in samples, which is an algorithm-only (analytical assay) performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Analytical Ground Truth: For most studies (LOQ, recovery, linearity, interfering substances, drug interference, metabolites), the ground truth was established through gravimetrical or volumetric preparation of samples with known, spiked concentrations of zonisamide or interfering substances.
- Comparative Ground Truth: For the method comparison study, the predicate device (QMS® Zonisamide Assay) served as the reference for comparison.
The sample size for the training set:
- The document does not describe a "training set" in the context of machine learning or AI. This assay is a chemical immunoassay, not a learning algorithm. The studies described are analytical validation studies to characterize the performance of the chemical reaction and measurement system.
How the ground truth for the training set was established:
- As there is no described training set, this question is 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 K091884.

807.92 (a)(1): Name: ARK Diagnostics, Inc.

Address: 1190 Bordeaux Drive Sunnyvale, CA 94089

Owner Operator Number: 10027663 Establishment Registration: 3005755244

Phone:	(408) 747-0700
FAX:	(408) 747-0783
Contact:	Kenneth C. Kasper, PhD - (408) 747-0708
	Executive Director of Quality and Regulatory Affairs

Date prepared: November 24, 2009

807.92 (a)(2): Device name- trade name and common name, and classification

Trade name:	ARK TM Zonisamide Assay
	ARK TM Zonisamide Calibrator
	ARK TM Zonisamide Control
Common Name:	Homogeneous Enzyme Immunoassay
Classification:	21 CFR 862.3350 NWM Diphenylhydantoin Test System; Class II(21 CFR 862.3200 DLJ, 21 CFR 862.3280 LAS)

807.92 (a)(3): Identification of the legally marketed predicate device

K051211

QMS® Zonisamide Assay, QMS® Zonisamide Calibrator Set, QMS® Zonisamide Control Set

ARK Diagnostics, Inc. - 510(k) Summary ARK Zonisamide Assay

page 1 of 9

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807.92 (a)(4): Device Description

807.92 (a)(5): Intended Use / Indications for Use

The ARK™ Zonisamide Calibrator is intended for use in calibration of the ARK Zonisamide Assay.

The ARK™ Zonisamide Control is intended for use in quality control of the ARK Zonisamide Assav.

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807.92 (a)(6): Technological Similarities and Differences to the Predicate

SUBSTANTIAL EQUIVALENCE COMPARATIVE CHART

Comparison between the ARKTM Zonisamide Assay and the Seradyn QMS® Zonisamide Assay

Characteristic	Device	Predicate
	ARK™ Zonisamide Assay	QMS® Zonisamide Assay K051211
Intended Use	The ARK™ Zonisamide Assay is intendedfor the quantitative determination ofzonisamide in human serum or plasma onautomated clinical chemistry analyzers.	The QMS® Zonisamide Assay is intendedfor the quantitative determination ofzonisamide in human serum or plasmasamples.
Indications for Use	Zonisamide concentrations can be used as anaid in management of patients treated withzonisamide.	Zonisamide concentrations can be used as anaid in management of patients treated withzonisamide.
Sample	Serum or plasma	Serum or plasma
Methodology	Homogenous enzyme immunoassay (EIA)	Homogenous particle-enhanced turbidimetricimmunoassay
ReagentComponents	Two (2) reagent system:	Two (2) reagent system:
	Anti-zonisamide Antibody/Substrate Reagent(R1) containing rabbit polyclonal antibodiesto zonisamide, glucose-6-phosphate,nicotinamide adenine dinucleotide, bovineserum albumin, preservatives, and stabilizers	The device consists of ready-to-use reagentscontaining rabbit polyclonal zonisamideantibodies in buffer (R1), and zonisamide-coated microparticles with (R2), both withazide preservative.
	Enzyme Reagent (R2) containing zonisamidelabeled with bacterial G6PDH, buffer, bovineserum albumin, preservatives, and stabilizers
	No special handling required. Reagents donot contain azide.
Platform required	Automated clinical chemistry analyzer	Automated clinical chemistry analyzer
	Validated on Hitachi 917	Validated on Hitachi 717
Accessory reagents	Calibrators (six levels) and controls (threelevels)	Calibrators (six levels) and controls (threelevels)
Testingenvironment	Routine clinical laboratory	Routine clinical laboratory
Reagent conditionand storage	Liquid, 2-8° C	Liquid, 2-8° C

ARK Diagnostics, Inc. – 510(k) Summary ARK Zonisamide Assay - K091884

page 3 of 9

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807.92 (b)(1) and 807.92 (b)(2): Brief Description of Nonclinical and Clinical Data

Limit of Quantitation (LOQ)

The LOQ of the ARK Zonisamide Assay was determined according to CLSI EP17-A and is defined as the lowest concentration for which acceptable inter-assay precision and recovery is observed (<20% CV with ±15% recovery). The LOQ was determined to be 2.0 µg/mL.

Recovery

Analytical recovery was performed by adding concentrated zonisamide drug into human serum negative for zonisamide. A stock concentrate of highly pure zonisamide was added volumetrically to human serum negative for zonisamide, representing drug concentrations across the assay range. Twenty replicates of each sample were assayed. The results were averaged and compared to the target concentration and percent recovery calculated. Results are shown below.

TheoreticalConcentration(µg/mL)	Mean RecoveredConcentration(µg/mL)	PercentRecovery
2.0	1.7	85.3
3.0	3.0	100.0
5.0	5.5	110.0
15.0	15.7	104.5
25.0	25.3	101.0
35.0	35.0	100.0
50.0	49.1	98.1

% Recovery = 100 X Mean recovered concentration Theoretical concentration

page 4 of 9

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Linearity

Linearity studies were performed as suggested in CLSI/NCCLS Protocol EP6-A. An 80.0 µg/mL serum sample was prepared and dilutions were made proportionally with human serum negative for zonisamide. Zonisamide concentrations ranged from 0.8 to 80.0 ug/mL. Linearity at specific dilutions was considered acceptable if the percent difference was ±10% between the predicted 150 and 200 order regressed values or ±15% below 3.0 µg/mL. A linear relationship between 2.4 and 48.0 µg/mL is shown below.

EstimatedValue(µg/mL)	Results(µg/mL)	1st OrderPredictedResults	2nd OrderPredictedResults	%Difference
2.4	2.3	2.5	2.3	-7.0
3.2	3.2	3.3	3.2	-3.8
4.0	4.1	4.1	4.0	-1.8
4.8	4.8	4.8	4.8	-0.6
5.6	5.8	5.6	5.6	0.3
6.4	6.7	6.4	6.5	1.0
7.2	7.4	7.2	7.3	1.4
8.0	8.2	8.0	8.1	1.8
16.0	16.2	15.7	16.2	2.7
24.0	23.4	23.5	24.0	2.3
32.0	32.0	31.3	31.7	1.4
40.0	39.7	39.1	39.2	0.4
48.0	45.8	46.8	46.5	-0.7

Assay Range

The range of the assay is 2.0 to 50.0 ug/mL. Report results below this range as <2.0 ug/mL. Report results above this range as >50.0 µg/mL.

Specimens testing initially above the assay range may be diluted in Calibrator A and retested. Multiply the assay result by the dilution factor to obtain the concentration of zonisamide in the undiluted specimen. The concentration after dilution must exceed the limit of quantitation and fall within the measuring range.

ARK Diagnostics, Inc. - 510(k) Summary ARK Zonisamide Assay - K091884

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Method Comparison

Correlation studies were performed using CLSI/NCCLS Protocol EP9-A2. Results from the ARK Zonisamide Assay were compared with results from a turbidimetric immunoassay. The zonisamide concentrations ranged from 6 ug/mL to 45 ug/mL. Results of the Passing-Bablok regression analysis for the study are shown below with 95% confidence limits shown in parentheses.

Slope	1.00	(0.96 to 1.00)
y-intercept	- 1.00	(- 1.00 to - 0.46)
Correlation Coefficient (r2)	0.93	(0.91 to 0.95)
Number of Samples	176

Precision

Precision was determined as described in CLSI/NCCLS Protocol EP5-A2. Tri-level controls containing zonisamide and pooled human serum specimens were used in the study. Each level of control was assayed in quadruplicate twice a day for 20 days. Each of the runs per day was separated by at least two hours. The within run, between day, total SD, and percent CVs were calculated. Results are shown below. Acceptance criteria: <10% total CV.

Sample	N	Mean(µg/mL)	Within Run		Between Day		Total
			SD	CV(%)	SD	CV(%)	SD	CV(%)
ARK Zonisamide Control
LOW	160	5.0	0.21	4.1	0.16	3.2	0.25	5.1
MID	160	24.4	0.96	3.8	0.56	2.3	1.12	4.5
HIGH	160	50.6	1.97	3.9	1.33	2.6	2.63	5.3
Human Serum
LOW	160	7.0	0.29	4.0	0.21	3.0	0.36	4.9
MID	160	22.6	0.81	3.5	0.59	2.6	1.01	4.4
HIGH	160	51.6	2.47	4.9	1.66	3.2	2.96	5.9

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Interfering Substances

Interference studies were conducted using CLSI/NCCLS Protocol EP7-A2 as a guideline. Clinically high concentrations of the following potentially interfering substances in serum with known levels of zonisamide (approximately 15 and 45 µg/mL) were evaluated. Each sample was assayed using the ARK Zonisamide Assay, along with a serum control of zonisamide. Measurement of zonisamide resulted in ≤10% error in the presence of interfering substances at the levels tested.

		Percentage Recovery
InterferingSubstance	InterferentConcentration	15 µg/mLZonisamide	45 µg/mLZonisamide
Albumin	12 g/dL	103.3	97.9
Bilirubin - conjugated	70 mg/dL	102.8	101.0
Bilirubin - unconjugated	70 mg/dL	100.1	98.8
Cholesterol	651 mg/dL	98.5	97.0
Gamma-Globulin	12 g/dL	97.3	101.4
Hemoglobin	1000 mg/dL	96.6	104.1
Intralipid®	1500 mg/dL	94.8	94.7
Rheumatoid Factor	1100 IU/mL	98.4	100.2
Triglycerides	1204 mg/dL	96.5	96.9
Uric Acid	30 mg/dL	98.5	99.4

Metabolites

N-acetyl zonisamide (NAZ) and the non-glucuronidated 2-sulfamoylacetyl phenol (SMAP) were evaluated. Metabolites NAZ and SMAP-glucuronide are found primarily in urine of patients administered zonisamide therapy. They have not been detected in plasma. Crossreactivity was evaluated in the presence of Low (15 ug/mL) and High (45 µg/mL) zonisamide.

Metabolite	Metabolite Conc(µg/mL)	PercentageCross-Reactivity		PercentageInterference
		LowZonisamide	HighZonisamide	LowZonisamide	HighZonisamide
NAZ	50.0	1.7	5.5	5.4	6.1
NAZ	10.0	5.3	3.3	3.3	0.7
SMAP	50.0	18.2	19.5	57.1	20.6
SMAP	10.0	14.8	27.3	8.8	5.8

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Drug Interference

Zonisamide-selective antibody did not crossreact with other anti-epileptic or coadministered drugs tested. A high concentration of each compound was spiked into normal human serum with known levels of zonisamide (approximately 15 and 45 µg/mL) and assayed along with a serum control of zonisamide. Measurement of zonisamide resulted in ≤ 10% error in the presence of drug compounds at the levels tested.

Compound	Concentration(µg/mL)	Percentage Recovery
		15 µg/mLZonisamide	45 µg/mLZonisamide
2-Ethyl-2-phenylmalonamide	1000	98.4	100.2
Acetaminophen	200	98.7	98.7
Acetyl Salicylic Acid	1000	100.3	102.3
Caffeine	100	97.0	97.5
Carbamazepine-10, 11-epoxide	120	99.9	100.9
Carbamazepine	120	101.7	100.8
10-Hydroxy Carbamazepine	100	96.6	93.5
Clonazepam	50	100.0	99.1
Cyclosporin A	40	101.2	104.9
Diazepam	20	98.0	100.8
Erythromycin	200	101.4	103.9
Ethosuximide	1000	99.9	100.5
Felbamate	1000	94.3	102.4
Gabapentin	100	100.9	105.3
Heparin	200 units/mL	104.1	102.7
Ibuprofen	500	101.3	105.9
Lamotrigine	300	100.0	99.8
Levetiracetam	400	95.6	97.9
L-Tryptophan	50	102.9	104.7
Oxcarbazepine	50	99.1	105.2
Phenobarbital	400	98.6	101.9
Phenytoin	200	105.1	106.7
Primidone	100	98.3	98.8
Salicylic Acid	500	104.7	106.6
Sulfamethoxazole	400	102.0	105.2
Sulfisoxazole	1000	95.8	98.3
Theophilline	250	101.7	100.3
Tiagabine	200	102.2	103.5
Topiramate	250	101.7	105.0
Trimethoprim	40	101.1	96.3
Valproic Acid	1000	99.8	101.2

ARK Diagnostics, Inc. - 510(k) Summary ARK Zonisamide Assay - K091884

page 8 of 9

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Anticoagulants

Studies were conducted to determine the performance characteristics of the assay for both serum and plasma samples containing zonisamide.

The results indicate that there is no significant difference between the recovery of zonisamide in serum or plasma.

Sample Stability

Serum specimens were shown to be stable for at least twenty-four (24) hours at room temperature (22°C), twenty-eight (28) days when refrigerated (2-8°C), fifty six (56) days frozen, and after three (3) successive freeze/thaw cycles.

On-Board Stability

Calibration Curve Stability: A stored calibration was effective up to 46 days based on supporting data.

Reagent on-board stability: Reagents were effective when stored after transfer to analyzer specific reagent containers for up to at least 32 days uncapped and 46 days capped based on supporting data. In-use stability of calibrator and controls was also demonstrated.

807.92 (b)(3): Conclusions from Nonclinical Testing

As summarized above, the ARK Zonisamide Assay, the ARK Zonisamide Calibrator and the ARK Zonisamide Control are substantially equivalent to the QMS® Zonisamide assay system. The ARK Zonisamide Assay system was shown to be safe and effective for its intended use based on performance studies.

ARK Diagnostics, Inc. - 510(k) Summary ARK Zonisamide Assay - K091884

page 9 of 9

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Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, representing health, services, and human aspects. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" is arranged around the upper half of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

ARK Diagnostics, Inc. c/o Mr. Johnny Valdez President 1190 Bordeaux Drive Sunnyvale, CA 94089

DEC - 9 2009

Re: K091884

Trade name: ARK Zonisamide Assay, Zonisamide Calibrator, ARK Zonisamide Control Regulation Number: 21 CFR 862.3350 Regulation Name: Diphenylhydantoin Test System Regulatory Class: Class II Product Code: NWM, DLJ, LAS Dated: November 11, 2009 Received: November 12, 2009

Dear Mr. Valdez:

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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket. surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

Courtney C. Harper, Ph.D. 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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Indication for Use

510(K) Number (if known): K091884

Device Name:

ARK™ Zonisamide Assay · ARK™ Zonisamide Calibrator ARK™ Zonisamide Control

Indications for Use:

The ARK™ Zonisamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Zonisamide in human serum or plasma on automated clinical chemistry analyzers.

Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide.

The ARK™ Zonisamide Calibrator is intended for use in calibration of the ARK Zonisamide Assay.

The ARK™ Zonisamide Control is intended for use in quality control of the ARK Zonisamide Assay.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (21 CFR Part 801 Subpart D)

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign Off

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

510(k) K091884

Regulation Number and Section

§ 862.3350 Diphenylhydantoin test system.

(a)
Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.(b)
Classification. Class II.