(184 days)
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No
The device description and performance studies describe a standard immunoassay for drug detection, with no mention of AI or ML techniques for analysis or interpretation.
No
This device is an in vitro diagnostic assay used for the qualitative analysis of propoxyphene in human urine. It is used in the diagnosis and treatment of propoxyphene use or overdose by providing analytical test results, not by directly treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose." Additionally, the "Device Description" mentions it is an "in vitro diagnostic assay."
No
The device description clearly states it is an "in vitro diagnostic assay" and describes a homogeneous enzyme immunoassay based on chemical reactions and spectrophotometric measurements. This indicates a physical test kit or system, 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 used for the qualitative analysis of propoxyphene in human urine and that the measurements are used in the diagnosis and treatment of propoxyphene use or overdose. This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The "Device Description" further clarifies that it is an in vitro diagnostic assay for the qualitative analysis of Propoxyphene in human urine.
- Specimen Type: The assay analyzes human urine, which is a specimen from the human body.
- Clinical Laboratories: The intended user is clinical laboratories, which are settings where IVD tests are typically performed.
Therefore, based on the provided information, this device clearly fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Propoxyphene assay is used for the qualitative analysis of propoxyphene in human urine with a cutoff of 300 ng/mL for used a clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose.
The Propoxyphene assay is calibrated with propoxyphene and will detect propoxyphene and its metabolites and analogs.
Product codes (comma separated list FDA assigned to the subject device)
JXN
Device Description
Propoxyphene is an in vitro diagnostic assay for the qualitative analysis of Propoxyphene in human urine. The assay is a homogeneous enzyme, immunoassay with a 300 ng/ml, cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts NAD to NADH, resulting in an absorbance change that can be measured spectrophotometrically.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human urine
Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratories.
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)
Comparative performance studies were conducted using the AEROSET® System. The Propoxyphene assay method comparison yielded acceptable correlation with the Emit II Propoxyphene assay on the SYVA®-30R Analyzer. The concordance table for the Propoxyphene assay shows 99% agreement. One sample was positive using the Emit II Propoxyphene assay on the SYVA®-30R Analyzer and negative using the Propoxyphene assay on the AEROSET® System. This sample was shown to contain 404 ng/mL of norpropoxyphene determined by GMN. The Propoxyphene assay method comparison yielded agreement with GC/MS. The clinical specimens tested ranged from 404 to 56,662 ng/ml. Precision studies were conducted using the Propoxyphene assay. The total %CV for Verifier I is 1.25%. The total %CV for the Cutoff Calibrator is 1.49%; the total %CV for Verifier II is 1.19%. The total %CV for the -25% Control of Cutoff Calibrator and the +25% Control of Cutoff Calibrator samples are 2.39% and 1.90%, respectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The Propoxyphene assay cutoff is 300 ng/mL. The limit of detection (sensitivity) of the Propoxyphene assay is 60 ng/ml.
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.
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.
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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).
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§ 862.3700 Propoxyphene test system.
(a)
Identification. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.(b)
Classification. Class II (special controls). A propoxyphene test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
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SIU(K) Summarv
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive MS 1-8 Irving, Texas 75038
MAR 2 0 2002 Contact Person Linda Morris Senior Regulatory Affairs Specialist Regulatory Affairs (972) 518-6711 Fax (972) 753-3367
Date of Preparation of this Summary: November 21, 2001 Device Trade or Proprietary Name: Propoxyphene Device Common/Usual Name or Classification Name: Propoxyphene Classification Number/Class: JXN/Class fl
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 GFR 807:92.
The assigned 510(k) number is: K013100.
Test Description:
Propoxyphene is an in vitro diagnostic assay for the qualitative analysis of Propoxyphene in human urine. The assay is a homogeneous enzyme, immunoussay with a 300 ng/ml, cutoff. The assay is based on competition between drug in the specifien and drug labeled with the enzyne glucose-6-phosphate dehydrogenase (G6PDH) for antibody birtting sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts NAD to NADH, tesulting in an absorbance change that can be measured spectrophotometrically.
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The Propoxyphene assay is substantially equivalent to the Emit® II Propoxyphene assay (K923873) on the SYVA®-30R Analyzer.
Both assays yield similar Performance Characteristics.
Similarities:
- Both assays are in vitro immunoassays. •
- . Both assays can be used for the qualitative analysis of Propoxyphene.
- . Both assays yield similar results.
- . Both assays are based on the competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites.
- . Both assays have the same assay ranges (cutoff).
Differences:
- The Propoxyphene assay is qualitative The Emit II Propoxyphene assay is qualitative and a semiquantitative.
Intended Use:
The Propoxyphene assay is used for the gralitative analysis of propoxyphene in human urine with a cutoff of 300 ng/mL. For use in clinical laboratories.
The Propoxyphene assay is calibrated with propoxyphene and will detect propoxyphene and its metabolites and analogs.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET® System. The Propoxyphicne assay method comparison yielded acceptable confelation with the Emit II Propox yphene assay on the SYVA-30R Analyzer. The concordance table for the Propoxyphene assay shows 99% agreement. One sample was positive using the Emit II Progoxybitene assay on the SYVA-30R Analyzer and negative using the Propoxyphene assay on the AEROSET System. This sample was shown to contain 404 ng/mL of norpropoxyphene determined by GMN. The Propoxyphene assay method comparison yielded
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agreement with GC/MS. The clinical speeimens tested ranged from 404 to 56,662 ng/ml.. Precision studies were conducted using the Propoxyobeneyassay. The total %CV for Verifier I is 1.25%. The total %CV for the Cutoff Calibrator is 1.49%; the total %CV for Verifier II is 1.19%. The total %CV for the - 25% Control of Cutoff Calibrator and the + 25% Control of Cutoff Calibrator samples are 2.39% and 1.90%, respectively. The Propoxyphene assay cutoff is 300 ng/mL. The limit of detection (sensitivity) of the Propoxyphene assay is 60 ng/m]. Mess data demonstrate that the performance of the Propoxyphene assay is substantially edition to the performance of the Emit II Propoxyphene assay on the SYVA-30R Analyzer
Conclusion:
The Propoxyphene assay is substantially equivalent to the Emit II Propoxyphene assay on the SYVA-30R Analyzer as demonstrated by results optained in the studies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other.
MAR 2 0 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Linda Morris Senior Regulatory Affairs Specialist Abbott Laboratories 1921 Hurd Dr. Irving. Texas 75038
Re: K013100
Trade/Device Name: Propoxyhene Regulation Number: 21 CFR 862.3700 Regulation Name: Propoxyphene test system Regulatory Class: Class II Product Code: JXN Dated: November 26, 2001 Received: November 28, 2001
Dear Ms. Morris:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K013100
Device Name: Propoxyphene
Indications For Use:
qualitative analysis of propoxyphene in human urir The Propoxyphene assay is used for with a cutoff of 300 ng/mL for used a cirfical laboratories. Measurements obtained by this device are used in the diagnosi; and treatinent of propoxyphene use or overdose.
The Propoxyphene assay is callbrated with propoxyphene and will detect propoxyphene an metabolites and analogs.
The Propoxyphene assay provides only a preliminary analytical test result. A more specific alternate chemical method must be in order to obtain a confirmed analytical result. G chromatography/mass spectronietry(GCAMS) is the prefected confirmatory method. Clinic consideration and professional judgment should be applied to any drug of abuse test result, sults are used. particularly when preliminary p
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use_ | Over-The-Counter Use_ |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
| (Division Sign-Off) Division of Clinical Laboratory Devices | |
| Number | K013100 51 |