(51 days)
No
The description focuses on a standard in vitro diagnostic test kit and its use on a clinical chemistry analyzer, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic test used for the diagnosis of methadone use or abuse, not for therapeutic purposes. It detects methadone in human urine but does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis of methadone use or abuse."
No
The device is an in vitro diagnostic test kit, which includes reagents and is intended for use on a specific hardware analyzer (Hitachi 917). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Abuscreen ONLINE Methadone is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine..."
The "Device Description" section also reiterates this: "Abuscreen ONLINE Methadone is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine..."
Furthermore, the device is intended for use in laboratories and the measurements are used in the diagnosis of methadone use or abuse, which are characteristics of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Abuscreen ONLINE Methadone is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of methadone use or abuse.
Product codes
DJR
Device Description
Abuscreen ONLINE Methadone is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of methadone use or abuse.
The proposed Abuscreen ONLINE Methadone test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Methadone test kit. The labeling and packaging have been changed for use on the Hitachi 917 Analyzer as well as an addition of a surfactant to the diluent. This modified test kit is not a replacement to the currently marketed kit.
The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit. Additional detailed information about the Hitachi 917 Analyzer is contained in volume II of the premarket notification (K953239) cleared on September 25, 1995.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratories
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)
The document discusses performance characteristics including:
Precision Qualitative (300 ng/mL Cutoff):
95% negative at 225 ng/mL
95% positive at 375 ng/mL
Within Run (Mean OD, CV%):
150 ng/mL: 5661, 1.1%
225 ng/mL: 4437, 1.9%
300 ng/mL: 3286, 1.4%
375 ng/mL: 2205, 1.9%
450 ng/mL: 1780, 2.7%
Day-to-Day (Mean OD, CV%):
150 ng/mL: 5541, 3.2%
225 ng/mL: 4308, 4.1%
300 ng/mL: 3212, 3.7%
375 ng/mL: 2146, 3.6%
450 ng/mL: 1749, 4.4%
Precision Quantitative (300 ng/mL Cutoff):
Within Run (Mean ng/mL, CV%):
150 ng/mL: 148, 2.4%
225 ng/mL: 220, 3.2%
300 ng/mL: 299, 1.5%
375 ng/mL: 411, 1.0%
450 ng/mL: 444, 0.8%
Day-to-Day (Mean ng/mL, CV%):
150 ng/mL: 151, 4.2%
225 ng/mL: 222, 3.7%
300 ng/mL: 303, 2.2%
375 ng/mL: 407, 2.0%
450 ng/mL: 452, 1.5%
Accuracy (300 ng/mL Cutoff):
N= 50 Confirmed Pos.
50 Pos. 0 Neg.
Limit of Detection: 19 ng/mL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics presented are "Precision Qualitative" and "Precision Quantitative" in terms of CV%, and "Accuracy" as confirmed positives matching detected positives. Specific sensitivity, specificity, PPV, NPV values are not explicitly stated, but can be inferred from the "Precision Qualitative" data regarding negative and positive percentages around the cutoff.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/1 description: The image shows the Roche logo. The logo consists of the word "Roche" written in black font inside of a hexagon. The hexagon is outlined in black.
510(k) Summary
Abuscreen ONLINE® Methadone
In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Identification of 510(k) Sponsor: I.
Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
510(k) Submission dated October 20, 1998
Rita Smith Contact: Senior Regulatory Affairs Associate Phone: (908) 253-7545 (908) 253-7547 Fax:
Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
1
II. Device Name:
The device name, including both the trade/proprietary name and the classification name are provided in the table below.
Table 1
| Product Name | Classification
Name | Product
Code | CFR
Number and
Regulatory Class |
|-----------------------------------|----------------------------------|-----------------|---------------------------------------|
| Abuscreen ONLINE for
Methadone | Enzyme Immunoassay,
Methadone | DJR | 862.3620
Class II |
III. Identification of the legally marketed device to which the 510(k) sponsor claims equivalence:
The following table identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.
| C
able
(
2
| 11 | |
|---|---|
| --------------------------- | -- |
| Product Name | Predicate Product
Name | 510(k) Number and Date
Predicate Cleared |
|-----------------------------------|-----------------------------------|---------------------------------------------|
| Abuscreen ONLINE for
Methadone | Abuscreen ONLINE for
Methadone | K930928 /24/93 |
2
Description of the Device/Statement of Intended Use: IV.
Abuscreen ONLINE Methadone is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of methadone use or abuse.
The proposed Abuscreen ONLINE Methadone test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Methadone test kit. The labeling and packaging have been changed for use on the Hitachi 917 Analyzer as well as an addition of a surfactant to the diluent. This modified test kit is not a replacement to the currently marketed kit.
The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit. Additional detailed information about the Hitachi 917 Analyzer is contained in volume II of the premarket notification (K953239) cleared on September 25, 1995.
Summary of the technological characteristics of the new device in comparison to V. those of the predicate.
Tables 3 outlines the technological characteristics (methodologies) of the Abuscreen ONLINE Methadone in comparison to that of the legally marketed predicate product.
3
Brief discussion of the clinical and nonclinical tests relied on for a determination of VI. substantial equivalence:
Tables 3 demonstrates the results of clinical and nonclinical studies performed using the Abuscreen ONLINE Methadone. The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in this chart. This information concludes that the performance of this device is essentially equivalent to the legally marketed predicate device.
4
Abuscreen ONLINE Methadone for Hitachi 917 Table 3
| Proposed: | Previously Cleared: (K930928) | ||||
|---|---|---|---|---|---|
| Abuscreen ONLINE Methadone | Abuscreen ONLINE Methadone | ||||
| for Hitachi 917 | (1000 Test Kit) | ||||
| Methodology | Kinetic interaction of | ||||
| microparticles in a solution as | |||||
| measured by changes in light | |||||
| transmission | Kinetic interaction of | ||||
| microparticles in a solution as | |||||
| measured by changes in light | |||||
| transmission | |||||
| Sample type | urine | urine | |||
| Intended Use | qualitative and semiquantitative | ||||
| detection of methadone | qualitative and semiquantitative | ||||
| detection of methadone | |||||
| Calibrator | Abuscreen ONLINE Calibration | ||||
| Pack or Abuscreen ONLINE | |||||
| Calibrator Level 3 | Abuscreen ONLINE Calibration | ||||
| Pack or Abuscreen ONLINE | |||||
| Calibrator Level 3 | |||||
| Cutoff(s) | 300 ng/mL | 300 ng/mL | |||
| Reagent (active | |||||
| ingredients) | 1. Ab reagent: methadone | ||||
| polyclonal (goat) antibody in | |||||
| buffer |
- Microparticle reagent:
Conjugated methadone
derivative microparticles in
buffer - Diluent: Buffer | | | 1. Ab reagent: methadone
polyclonal (goat) antibody in
buffer - Microparticle reagent:
Conjugated methadone
derivative microparticles in
buffer - Diluent: Buffer | |
| Performance Characteristics: | | | | | |
| Precision Qualitative (300 ng/mL Cutoff): | | | | | |
| | >95% negative at 225 ng/mL | | | >95% negative at 240 ng/mL | |
| | >95% positive at 375 ng/mL | | | >95% positive at 360 ng/mLL | |
| Within Run | Mean (OD) | CV% | | | |
| 150 ng/mL | 5661 | 1.1 | | | |
| 225 ng/mL | 4437 | 1.9 | | | |
| 300 ng/mL | 3286 | 1.4 | | | |
| 375 ng/mL | 2205 | 1.9 | | | |
| 450 ng/mL | 1780 | 2.7 | | | |
| Day-to-Day | Mean (OD) | CV% | | | |
| 150 ng/mL | 5541 | 3.2 | | | |
| 225 ng/mL | 4308 | 4.1 | | | |
| 300 ng/mL | 3212 | 3.7 | | | |
| 375 ng/mL | 2146 | 3.6 | | | |
| 450 ng/mL | 1749 | 4.4 | | | |
| Proposed: | | | Previously Cleared: (K930928) | | |
| Abuscreen ONLINE | | | Abuscreen ONLINE Methadone | | |
| Methadone for Hitachi 917 | | | (1000 Test Kit) | | |
| Precision Quantitative ( 300 ng/mL Cutoff ): | | | | | |
| Within Run | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 150 ng/mL | 148 | 2.4 | 150 | 152 | 4 |
| 225 ng/mL | 220 | 3.2 | 240 | 235 | 3 |
| 300 ng/mL | 299 | 1.5 | 300 | 301 | 1 |
| 375 ng/mL | 411 | 1.0 | 340 | 340 | 1 |
| 450 ng/mL | 444 | 0.8 | | | |
| Day-to-Day | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 150 ng/mL | 151 | 4.2 | 150 | 151 | 4 |
| 225 ng/mL | 222 | 3.7 | 240 | 236 | 3 |
| 300 ng/mL | 303 | 2.2 | 300 | 297 | 3 |
| 375 ng/mL | 407 | 2.0 | 340 | 340 | 1 |
| 450 ng/mL | 452 | 1.5 | | | |
| Accuracy | | | | | |
| 300 ng/mL Cutoff | N= 50 Confirmed Pos.
50 Pos. 0 Neg. | | N = 73 Confirmed Pos.
73 Pos. 0 Neg. | | |
| Limit of Detection | 19 ng/mL | |