(91 days)
Not Found
No
The summary describes a fluorescence immunoassay and mentions method comparisons and analytical performance, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a diagnostic tool used to detect the presence of drugs in urine, not to treat or cure a disease or condition.
Yes
The device is intended for the qualitative determination of the presence of drugs and/or their major metabolites in urine, providing preliminary test results for clinical consideration. This function aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "fluorescence immunoassay intended to be used with the Triage Meters". This indicates a physical assay and a meter (hardware) are integral components of the device, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states the device is for the "qualitative determination of the presence of drug and/or the major metabolites... in urine." This is a classic description of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide diagnostic information (presence of drugs).
- Device Description: It describes a "fluorescence immunoassay," which is a common technology used in IVD tests to detect specific substances in biological samples.
- Performance Studies: The document details performance studies comparing the device to other methods (Biosite Triage 8 Panel for Drugs of Abuse and GC/MS) using clinical specimens. This type of validation is standard for IVD devices to demonstrate their accuracy and reliability.
- Predicate Devices: The mention of predicate devices (K973784 and K043242) which are also IVD drug screening tests, further supports that this device falls under the IVD category.
- Point-of-Care: While it's a point-of-care device, this refers to the location of use, not whether it's an IVD. Many IVD tests are designed for point-of-care settings.
N/A
Intended Use / Indications for Use
The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.
The threshold concentrations are provided below:
| Acetaminophen/Paracetamol | APAP | 5 µg/mL |
|---|---|---|
| Amphetamines | AMP | 1000 ng/mL |
| Methamphetamines | mAMP | 1000 ng/mL |
| Barbiturates | BAR | 300 ng/mL |
| Benzodiazepines | BZO | 300 ng/mL |
| Cocaine | COC | 300 ng/mL |
| Methadone | MTD | 300 ng/mL |
| Opiates | OPI | 300 ng/mL |
| Phencyclidine | PCP | 25 ng/mL |
| THC | THC | 50 ng/mL |
| Tricyclic Antidepressants | TCA | 1000 ng/mL |
This test provides only preliminary test results. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmatory method.
A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.
Product codes (comma separated list FDA assigned to the subject device)
DJR
Device Description
The Triage TOX Drug Screen Methadone assay is a fluorescence immunoassay intended to be used with the Triage MeterPlus for the point-of-care qualitative determination of methadone in urine.
The Triage Methadone assay is identical in principle, reagents and procedure to the previously cleared Triage TOX Drug Screen (FDA file number K043242). The only difference between the two tests is that an assay for methadone has been added.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
point-of-care
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)
A method comparison of the Triage TOX Drug Screen Methadone assay with the Biosite Triage 8 Panel for Drugs of Abuse was performed using 102 specimens obtained from clinical sources. The overall agreement was 96.1%. Discordant samples were determined by GC/MS to contain I-methadone at concentrations greater than 175 ng/mL (the established threshold concentration of the GC/MS method for the i-methadone enantiomer) but less than the threshold concentration of the Triage 8 Panel for Drugs of Abuse (300 ng/mL). Based on this, the percent agreement versus the claimed specificity for the distinct methadone enantiomers would be 100%. The analytical performance characteristics of the assay were equivalent with predicate methods.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
overall agreement was 96.1%
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.
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
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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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Image /page/0/Picture/1 description: The image shows the text 'K 060791' in a handwritten style. The text appears to be a code or identifier. The characters are bold and slightly slanted.
510(k) Summary of Safety and Effectiveness II.
In accordance with the provisions of Section 4 of the Safe Medical Devices Act of 1990 and 21 CFR 807.92, the following summary is provided. Biosite requests that this document be maintained CONFIDENTIAL until such time that the product is cleared by the Food and Drug Administration via the 510(k) Notification Process and in accordance with the provisions of the Act.
A. Name and Address of Submitter
| Company Name: | Biosite Incorporated |
|---|---|
| Address: | 9975 Summers Ridge Road |
| San Diego, CA 92121 | |
| Telephone: | (888) 246-7483 |
| Fax: | (858) 586-7543 |
| Contact Person: | Robin Weiner |
| Date Summary Prepared: | 03/22/06 |
B. Device Names
Triage® TOX Drug Screen
C. Predicate Devices
Biosite Triage® 8 Panel for Drugs of Abuse [FDA file number K973784] Biosite Triage® TOX Drug Screen [FDA file number K043242]
D. Device Description and Intended Use
The Triage TOX Drug Screen Methadone assay is a fluorescence immunoassay intended to be used with the Triage MeterPlus for the point-of-care qualitative determination of methadone in urine.
The Triage Methadone assay is identical in principle, reagents and procedure to the previously cleared Triage TOX Drug Screen (FDA file number K043242). The only difference between the two tests is that an assay for methadone has been added
E. Summary of Comparison Data
A method comparison of the Triage TOX Drug Screen Methadone assay with the Biosite Triage 8 Panel for Drugs of Abuse was performed using 102 specimens obtained from clinical sources. The overall agreement was 96.1%. Discordant samples were determined by GC/MS to contain I-methadone at concentrations greater than 175 ng/mL (the established threshold concentration of the GC/MS method for the i-methadone enantiomer) but less than the threshold concentration of the Triage 8 Panel for Drugs of Abuse (300 ng/mL). Based on this, the percent agreement versus the claimed specificity for the distinct methadone enantiomers would be 100%. The analytical performance characteristics of the assay were equivalent with predicate methods.
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F. Conclusion
In conclusion, these studies demonstrate the substantial equivalence of the Triage TOX Drug Screen Methadone assay to existing products already marketed for detecting the presence of various drugs of abuse. They further demonstrate the suitability of the product for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.
: . . . .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 is a stylized eagle emblem, with three curved lines representing the eagle's body and wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 22 2006 Ms. Robin Weiner Vice President, Regulatory and Government Affairs Biosite Incorporated 9975 Summers Ridge Road San Diego, CA 92121
Re: K060791
Trade/Device Name: Triage® TOX Drug Screen Regulation Number: 21 CFR8862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR Dated: June 6, 2006 Received: June 9, 2006
Dear Ms. Weiner:
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).
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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) 276-0484. 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 ne (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Alberto G.
Alberto Gutierrez, 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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Indications for Use
510(k) Number (if known): K060791
Device Name: Triage® TOX Drug Screen
Indications For Use:
The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.
The threshold concentrations are provided below:
| Acetaminophen/Paracetamol | APAP | 5 µg/mL |
|---|---|---|
| Amphetamines | AMP | 1000 ng/mL |
| Methamphetamines | mAMP | 1000 ng/mL |
| Barbiturates | BAR | 300 ng/mL |
| Benzodiazepines | BZO | 300 ng/mL |
| Cocaine | COC | 300 ng/mL |
| Methadone | MTD | 300 ng/mL |
| Opiates | OPI | 300 ng/mL |
| Phencyclidine | PCP | 25 ng/mL |
| THC | THC | 50 ng/mL |
| Tricyclic Antidepressants | TCA | 1000 ng/mL |
This test provides only preliminary test results. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmatory method.
A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of D ODRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
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Office of In Vit o Diagnostic Device Evaluation and Sa
5100(k) K060791