ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33

K081231 · Abbott Laboratories · DLZ · Sep 26, 2008 · Clinical Toxicology

Device Facts

• Record ID: K081231
• Device Name: ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33
• Applicant: Abbott Laboratories
• Product Code: DLZ · Clinical Toxicology
• Decision Date: Sep 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3660
• Device Class: Class 2

Intended Use

The ARCHITECT iPhenobarbital assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenobarbital, an anticonvulsant and sedative-hypnotic drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.

Device Story

The ARCHITECT iPhenobarbital assay is a one-step STAT chemiluminescent microparticle immunoassay (CMIA) used on the ARCHITECT i System. It measures phenobarbital levels in human serum or plasma. The process involves combining the patient sample with anti-phenobarbital coated paramagnetic microparticles and phenobarbital acridinium-labeled conjugate. The microparticles bind to both the phenobarbital in the sample and the labeled conjugate. After washing, trigger solutions are added to initiate a chemiluminescent reaction. The system optics measure the resulting relative light units (RLUs). An indirect relationship exists between the phenobarbital concentration and the detected RLUs. The device is intended for use in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing phenobarbital overdose and monitoring therapeutic drug levels to ensure appropriate patient management.

Clinical Evidence

No clinical trials performed. Evidence consists of analytical bench testing: precision (total CVs 2.9–4.6% across therapeutic range), linearity (R² ≥ 0.998), and interference studies. Method comparison study (n=132) against predicate showed high correlation (r > 0.999) with a Passing-Bablok slope of 0.93 and average bias of -8.1%.

Technological Characteristics

Chemiluminescent microparticle immunoassay (CMIA) technology. Components include anti-phenobarbital coated paramagnetic microparticles and phenobarbital acridinium-labeled conjugate. Operates on the ARCHITECT i System with STAT protocol capability. Measures chemiluminescence as relative light units (RLUs).

Indications for Use

Indicated for quantitative measurement of phenobarbital in human serum or plasma for patients requiring monitoring of anticonvulsant/sedative-hypnotic therapy or diagnosis of overdose.

Regulatory Classification

Identification

A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.

Predicate Devices

• AxSYM Phenobarbital (k940596)

Submission Summary (Full Text)

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# SEP 2 6 2008

### ARCHITECT iPhenobarbital

# 510(k) Summary (Summary of Safety and Effectiveness)

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

### Applicant Name:

Carol Jochum Senior Regulatory Affairs Specialist Abbott Laboratories 100 Abbott Park Road Abbott Park, IL 60064

#### Device Name:

## Reagents:

Classification Name: Phenobarbital test system Trade Name: ARCHITECT iPhenobarbital Immunoassay Common Name: Phenobarbital test Governing Regulation: 862.3660 Device Classification: Class II Classification Panel: Toxicology Product Code: DLZ

#### Calibrators:

Classification Name: Calibrator, drug specific Trade Name: ARCHITECT iPhenobarbital Calibrators (A-F) Common Name: Calibrator Governing Regulation: 862.3200 Device Classification: Class II Classification Panel: Toxicology Product Code: DLJ

ARCHITECT iPhenobarbital 510(k) Submission

Page 1 of 3

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#### Legally marketed device to which equivalency is claimed:

AxSYM Phenobarbital (K940596)

### Intended Use of Device:

The ARCHITECT i Phenobarbital assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenobarbital, an anticonvulsant and sedative-hypnotic drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.

# Description of Device:

The ARCHITECT i Phenobarbital assay is a one-step STAT immunoassay for the quantitative measurement of phenobarbital in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Sample, antiphenobarbital coated paramagnetic microparticles, and phenobarbital acridiniumlabeled conjugate are combined to create a reaction mixture. The anti-phenobarbital coated microparticles bind to phenobarbital present in the sample and to the phenobarbital acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of phenobarbital in the sample and the RLUs detected by the ARCHITECT i System optics.

ARCHITECT iPhenobarbital 510(k) Submission

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### Comparison of Technological Characteristics:

The ARCHITECT i Phenobarbital assay is a chemiluminescent microparticle immunoassay (CMIA) method for the quantitative measurement of phenobarbital, an anticonvulsant and sedative-hypnotic drug, in human serum and plasma. The AxSYM Phenobarbital assay utilizes fluorescence polarization immunoassay (FPIA) technology for the measurement of phenobarbital, an anticonvulsant and sedative-hypnotic drug, in serum or plasma.

### Summary of Non-Clinical Performance:

The ARCHITECT iPhenobarbital assay is substantially equivalent to the AxSYM Phenobarbital assay in terms of precision, linearity and interferences as demonstrated in non-clinical performance data in this 510(k) submission.

### Summary of Clinical Performance:

The ARCHITECT iPhenobarbital demonstrated substantially equivalent performance to the AxSYM Phenobarbital with a correlation coefficient of 1.0.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three wing-like shapes. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 6 2008

Abbott Laboratories c/o Ms. Carol Jochum AP 6C-2, Dept. 049C 100 Abbott Park Road Abbott Park, IL 60064

| Re: | k081231 |
|--------------------|------------------------------------------------------------------------------|
| Trade/Device Name: | ARCHITECT iPhenobarbital Assay<br>ARCHITECT iPhenobarbital Calibrators (A-F) |
| Regulation Number: | 21 CFR 862.3660 |
| Regulation Name: | Phenobarbital test system |
| Regulatory Class: | Class II |
| Product Code: | DLZ, DLJ |
| Dated: | September 9, 2008 |
| Received: | September 10, 2008 |

Dear Ms. Jochum:

We have reviewed your Scction 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 nrior 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 n your device to such additional controls. Existing major regulations affecting your device can be four o in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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 [phone]. 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 [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Sean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### Indication for Use

510(k) Number (if known): KOE (23 )

Device Name: ARCHITECT iPhenobarbital

Indication for Use:

#### Reagents

The ARCHITECT iPhenobarbital assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenobarbital, an anticonvulsant and sedative-hypnotic drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.

#### Calibrators

The ARCHITECT iPhenobarbital Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of phenobarbital in human serum or plasma.

Prescription Use X (Part 21 CFR 801 Subpart D) And/Or

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 18/23/ 510(k)