(148 days)
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No
The summary describes a standard immunoassay technology (CMIA) and does not mention any AI or ML components in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic (IVD) assay designed to measure phenobarbital levels in human samples, which is used to monitor drug levels and diagnose overdose, not to directly treat or prevent a disease.
Yes.
The "Intended Use / Indications for Use" section explicitly states that "The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose...".
No
The device description clearly outlines a chemiluminescent microparticle immunoassay (CMIA) which involves physical reagents (microparticles, conjugate, solutions) and a hardware system (ARCHITECT i System) to measure relative light units. This is a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is "in vitro" and is used for the "quantitative measurement of phenobarbital... in human serum or plasma." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body.
- Device Description: The description details a laboratory-based assay using chemical reactions (chemiluminescent microparticle immunoassay) to analyze a biological sample (serum or plasma). This is characteristic of an IVD.
- Performance Studies: The summary of performance studies describes testing the device's performance using biological samples and comparing it to a predicate device, which is standard practice for demonstrating the performance of an IVD.
N/A
Intended Use / Indications for Use
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. 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.
Product codes
DLZ, DLJ
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The ARCHITECT iPhenobarbital demonstrated substantially equivalent performance to the AxSYM Phenobarbital with a correlation coefficient of 1.0.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient of 1.0
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.
AxSYM Phenobarbital (K940596)
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
§ 862.3660 Phenobarbital test system.
(a)
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.(b)
Classification. Class II.
0
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
1
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
2
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.
3
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 |
| 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).
4
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. 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
5
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)
(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)
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Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 18/23/ 510(k)