(244 days)
TUBI's UNISCAN-DoA is a system intended for use in Drugs of Abuse Screening Tests.
This mAMP/Opi/THC panel test is a prescription assay intended for use with UNISCAN-DoA scanner in laboratory by professional personnel. The mAMP/Opi/THC assays were calibrated with d-methamphetamine/morphine/11-nor-△-THC-9-COOH, respectively. It provides qualitative screening results for Methamphetamine/ Opiate/cannabinoids in human urine at a cutoff concentration of 1000/300/50 ng/ml. For In Vitro Diagnostic Use.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any Drug of Abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the recommended confirmatory method.
The UNISCAN-DoA system includes UNISCAN-DoA scanner and mAMP/Opi/THC panel test.
The UNISCAN-DoA scanner is a scientific measurement device for color intensity of developed test strip. The color intensity of a test line is detected by the contact image sensor (CIS) inside the device.
The test strip of UNISCAN-DoA system is a one-step, colloidal gold based chromatographic immunoassay for the rapid, qualitative detection of Methamphetamine, Opiates, and THC (Cannabinoid).
The device contains a membrane strip, which is pre-coated with drug-protein conjugate at the test region of the membrane strip. A wicking pad containing anti-drug monoclonal antibody-conjugate is placed at one end of the membrane. The device contains a control region which has a different antigen/antibody from the test region.
The assay relies on the competition for binding antibody between drug conjugate and free drug that may be present in the urine specimen being tested. When drug is present in the urine specimen, it competes with drug conjugate for limited amount of antibody-colloidal gold conjugate. If the drug is present in the urine specimen, it will prevent the binding of drug conjugate to the antibody. Therefore, the color intensity of the test line is reduced. The higher the drug concentration is present in the urine specimen, the lower the color intensity is in the test line of a strip. The color intensity of a test line is inversely proportional to the drug concentration in the urine specimen. The correlation between the color intensity and the drug concentration is described by a calibration curve, whose coefficients are determined via nonlinear regression based on the experimental data. The calibration curve equation and its coefficients are stored in UNISCAN-DoA scanner. Once a developed test strip is inserted into the scanner and is scanned by the device, the color intensity of a test line is detected by the contact image sensor (CIS) inside the device and the signal is converted to drug concentration according to the stored calibration curve equation and its coefficients. The qualitative result is then displayed on the LCD screen of the device.
A control line is present at the control region to work as procedural control. This colored band should always appear at the control region regardless the presence of drugs or metabolite. The UNISCAN-DoA scanner automatically detects the color intensity of a control line. If the control line of an inserted test strip does not be detected by the device, "Strip is Failed!" will be displayed on the LCD screen of the device.
The provided text describes the UNISCAN-DoA system, which consists of a scanner and a mAMP/Opi/THC panel test for qualitative detection of Methamphetamine, Opiates, and THC in human urine. The performance is evaluated against GC/MS analysis.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a pass/fail threshold. However, it presents "Agreement among positives" and "Agreement among negatives" as key performance metrics. We can infer that high percentages in these categories are desirable for acceptance.
| Assay | Performance Metric | Reported Device Performance |
|---|---|---|
| mAMP | Agreement among positives | 97.9% (47/48) |
| Agreement among negatives | 95.9% (47/49) | |
| Opi | Agreement among positives | 95.7% (44/46) |
| Agreement among negatives | 100% (48/48) | |
| THC | Agreement among positives | 97.8% (45/46) |
| Agreement among negatives | 97.9% (47/48) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- mAMP: 97 urine specimens
- Opi: 94 urine specimens
- THC: 94 urine specimens
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions studies were conducted to evaluate performance.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not mention the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of human reader improvement with AI assistance. The device is a standalone immunoassay system, not an AI-assisted interpretation system for human readers.
6. Standalone Performance Study
Yes, a standalone performance study was clearly done. The performance metrics (Agreement among positives/negatives) are reported for the UNISCAN-DoA system itself, comparing its results to a confirmed analytical method (GC/MS).
7. Type of Ground Truth Used
The ground truth used was Gas Chromatography/Mass Spectroscopy (GC/MS) analysis. This is stated as the recommended confirmatory method: "To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the recommended confirmatory method."
8. Sample Size for the Training Set
The document does not provide information on a separate training set or its sample size. The calibration curve (which could be considered part of model training/fitting) is mentioned: "The correlation between the color intensity and the drug concentration is described by a calibration curve, whose coefficients are determined via nonlinear regression based on the experimental data. The calibration curve equation and its coefficients are stored in UNISCAN-DoA scanner." However, the data used for this calibration is not specified as a "training set" with details like sample size. It's more implied as part of the initial device development.
9. How the Ground Truth for the Training Set Was Established
As mentioned above, the document does not explicitly detail a separate "training set" or how its ground truth was established. The calibration curve's coefficients are determined by "nonlinear regression based on the experimental data," but the specifics of this experimental data and its ground truth establishment are not provided for a distinct training phase. It's likely that standards and known concentrations were used, but not specified as a "training set" with ground truth in the context of the study reported.
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K0J0347
- 510(k) Summary
OCT - 9 2008
510(k) Summary
as required by section 807.92(c)
Identification: UNISCAN-DoA system
-
- USDoA-01: UNISCAN-DoA Scanner
-
- SUDoA-01: mAMP/Opi/THC panel test
Description: The UNISCAN-DoA system includes UNISCAN-DoA scanner and mAMP/Opi/THC panel test.
The UNISCAN-DoA scanner is a scientific measurement device for color intensity of developed test strip. The color intensity of a test line is detected by the contact image sensor (CIS) inside the device.
The test strip of UNISCAN-DoA system is a one-step, colloidal gold based chromatographic immunoassay for the rapid, qualitative detection of Methamphetamine, Opiates, and THC (Cannabinoid).
Proprietary and Established Names: UNISCANTM -DoA system UNISCAN-DoA Scanner mAMP/Opi/THC Panel test
Name of Manufacturer: Taiwan Unison Biotech Inc. (TUBI) 3F, No. 22, Kedung 3rd road, Chunan, Miaoli 350, Taiwan, ROC Tel: +886-37-586345 Fax: +886-37-586329
Contact Person:
Kuang-Pin Hsiung 3F, No. 22, Kedung 3rd road, Chunan, Miaoli 350, Taiwan, ROC Tel: +886-37-586345 Fax: +886-37-586329
Intended Use: This mAMP/Opi/THC panel test is a prescription assay intended for use with UNISCAN-DoA scanner in laboratory by professional personnel. The mAMP/Opi/THC assays were calibrated with
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d-methamphetamine/morphine/11-nor-△9-THC-9-COOH, respectively. It provides qualitative screening results for Methamphetamine/ Opiate/cannabinoids in human urine at a cutoff concentration of 1000/300/50 ng/ml. For In Vitro Diagnostic Use.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any Drug of Abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the recommended confirmatory method.
Technology: UNISCAN-DoA system, like multi-drug tests from other manufacturer such as Roche, American Biotech Inc, and Forefront Diagnostic Inc, etc., detects the presence of target drugs or their metabolites by one step, chromatographic, and competitive immunoassay technology. Currently marketed Triage TOX Drug Screen (whose 510(k) number is K043242) is used for substantial equivalence predicate kit. All of these products are based on the same immunochemical principle of recognition and formation of specific antibody / target drug / antibody / complexes.
The device contains a membrane strip, which is pre-coated with drug-protein conjugate at the test region of the membrane strip. A wicking pad containing anti-drug monoclonal antibody-conjugate is placed at one end of the membrane. The device contains a control region which has a different antigen/antibody from the test region.
The assay relies on the competition for binding antibody between drug conjugate and free drug that may be present in the urine specimen being tested. When drug is present in the urine specimen, it competes with drug conjugate for limited amount of antibody-colloidal gold conjugate. If the drug is present in the urine specimen, it will prevent the binding of drug conjugate to the antibody. Therefore, the color intensity of the test line is reduced. The higher the drug concentration is present in the urine specimen, the lower the color intensity is in the test line of a strip. The color intensity of a test line is inversely proportional to the drug concentration in the urine specimen. The correlation between the color intensity and the drug concentration is described by a calibration curve, whose coefficients are determined via nonlinear regression based on the experimental data. The calibration curve equation and its coefficients are stored in UNISCAN-DoA scanner. Once a developed test strip is inserted into the
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scanner and is scanned by the device, the color intensity of a test line is detected by the contact image sensor (CIS) inside the device and the signal is converted to drug concentration according to the stored calibration curve equation and its coefficients. The qualitative result is then displayed on the LCD screen of the device.
A control line is present at the control region to work as procedural control. This colored band should always appear at the control region regardless the presence of drugs or metabolite. The UNISCAN-DoA scanner automatically detects the color intensity of a control line. If the control line of an inserted test strip does not be detected by the device, "Strip is Failed!" will be displayed on the LCD screen of the device.
Performance: The product performance characteristics of UNISCAN-DoA system was evaluated in studies. The results of these studies demonstrated that UNISCAN-DoA system can be performed by professional and laboratory personnel to obtain a qualitative and rapid detection of drugs of abuse.
| UNISCANResults | Less than half thecutoff concentrationby GC/MS analysis | Near CutoffNegative (Between50% below thecutoff and the cutoffconcentration) | Near CutoffPositive (Betweenthe cutoff and 50%above the cutoffconcentration) | High Positive(greater than 50%above the cutoffconcentration) |
|---|---|---|---|---|
| Positive | 0 | 2 | 5 | 42 |
| Negative | 43 | 4 | 1 | 0 |
a. mAMP: 97 urine specimens were used to evaluate the performance of mAMP assay.
% Agreement among positives is 97.9% (47/48)
% Agreement among negatives is 95.9% (47/49)
| UNISCANResults | Less than half thecutoff concentrationby GC/MS analysis | Near CutoffNegative (Between50% below thecutoff and the cutoffconcentration) | Near CutoffPositive (Betweenthe cutoff and 50%above the cutoffconcentration) | High Positive(greater than 50%above the cutoffconcentration) |
|---|---|---|---|---|
| Positive | 0 | 0 | 3 | 41 |
| Negative | 43 | 5 | 2 | 0 |
b. Opi: 94 urine specimens were used to evaluate the performance of Opi assay.
% Agreement among positives is 95.7% (44/46)
% Agreement among negatives is 100% (48/48)
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| UNISCANResults | Less than half thecutoff concentrationby GC/MS analysis | Near CutoffNegative (Between50% below thecutoff and the cutoffconcentration) | Near CutoffPositive (Betweenthe cutoff and 50%above the cutoffconcentration) | High Positive(greater than 50%above the cutoffconcentration) |
|---|---|---|---|---|
| Positive | 0 | 1 | 4 | 41 |
| Negative | 43 | 4 | 1 | 0 |
c. THC: 94 urine specimens were used to evaluate the performance of THC assay
% Agreement among positives is 97.8% (45/46)
% Agreement among negatives is 97.9% (47/48)
Conclusion: Both subject and predicate device Triage TOX Drug Screen (whose 510(k) number is K043242) are qualitative immunochromatographic single-use tests for measurement of the same analyte(s) in the same matrix. Both subject and predicate devices are competitive immunoassays.
The studies demonstrate the substantial equivalence of Uniscan-DoA system to existing products already marketed for screening drugs of abuse. The safety and effectiveness of the subject are established and it is appropriate for commercial distribution.
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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Taiwan Uniscon Biotech, Inc. c/o Tzu-Wei Li Center for Measurement Standards/Industrial Technology Research Institute 321 Kuang Fu Road, Sec 2, Bldg. 16 Hsinchu, (Taiwan) China
OCT - 9 2008
Re: K080347
Trade/Device Name: mAmp/Opi/THC Panel Test with SUDoA-01 Scanner Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine Test System. Regulatory Class: Class II Product Codes: DJC, DJG, LDJ Dated: September 23, 2008 Received: September 25, 2008
Dear Tzu-Wei Li:
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) 276-0490. 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.
Yéan 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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4. Indication for Use Statement
Indication for Use
510(k) Number (if known):
Device Name: UNISCAN-DoA system_ 1. USDoA-01: UNISCAN-DoA Scanner 2. SUDoA-01: mAMP/Opi/THC panel test
Indication for Use:
TUBI's UNISCAN-DoA is a system intended for use in Drugs of Abuse Screening Tests.
This mAMP/Opi/THC panel test is a prescription assay intended for use with UNISCAN-DoA scanner in laboratory by professional personnel. The mAMP/Opi/THC assays were calibrated with d-methamphetamine/morphine/11-nor-△-THC-9-COOH, respectively. It provides qualitative screening results for Methamphetamine/ Opiate/cannabinoids in human urine at a cutoff concentration of 1000/300/50 ng/ml. For In Vitro Diagnostic Use.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any Drug of Abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the recommended confirmatory method.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 (OVD)
Signature
Diysion Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080347
Section 4, page 1 of 1
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).