(121 days)
The Abuscreen OnLine II for Opiates 300/2000 Reagent is an in vitro diagnostic test for the qualitative (at 300 and 2000 ng/mL cutoff) and semi-quantitative (at 2000 ng/mL cutoff) detection of morphine and its metabolites in human urine.
The Abuscreen ONLINE Opiates Calibration Pack is an in vitro diagnostic device designed for the calibration of the Roche reagent assays for opiates.
The Roche Abuscreen ONLINE Opiates Control Pack is an assayed quality control sample for use with the Roche assays for opiates.
The Abuscreen OnLine II for Opiates 300/2000 Reagent is an in vitro diagnostic test for the qualitative (at 300 and 2000 ug/mL cutoff) and serni-quantitative (at 2000 ng/mL cutoff) detection of morphine and its metabolites in human urine.
The Abuscreen OnLine Opiates Calibration Pack is an in vitro diagnostic device designed for the calibration of the Roche reagent assays for opiates.
The Roche Abuscreen ONLINE Opiates Control Pack is an assayed quality control sample for use with the Roche assays for opiates.
The Abuscreen OnLine II for Opiates 300/2000 Reagent is an in vitro diagnostic test designed for the qualitative and semi-quantitative detection of morphine and its metabolites in human urine. The following describes its acceptance criteria and the study that demonstrates its performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Abuscreen OnLine II Opiates Reagent) |
|---|---|---|
| 300 ng/mL Qualitative Application | ||
| Assay Range | Up to 600 ng/mL | Up to 2000 ng/mL |
| Precision (Negative Reading) | >95% confidence at 80% cutoff | >95% confidence at 80% cutoff |
| Precision (Positive Reading) | >95% confidence at 120% cutoff | >95% confidence at 120% cutoff |
| Accuracy (% Agreement vs. GC/MS) | 100% (N=49) | 100% (N=40) |
| Sensitivity (Analytical) | < 5.0 ng/mL | < 12 ng/mL |
| 2000 ng/mL Quantitative Application | ||
| Assay Range | Up to 4000 ng/mL | Up to 8000 ng/mL |
| Precision (Within-run) | 1.7% at 246 ng/mL, 1.7% at 297 ng/mL, 0.7% at 359 ng/mL | 2.2% at 1000 ng/mL, 3.3% at 1600 ng/mL, 2.8% at 2000 ng/mL, 3.8% at 2400 ng/mL, 4.2% at 4000 ng/mL |
| Accuracy (% Agreement vs. GC/MS) | 100% (N=49) | 100% (N=42) |
| Sensitivity (Analytical) | < 5.0 ng/mL | < 12 ng/mL |
2. Sample Sizes Used for the Test Set and Data Provenance
- Accuracy (300 ng/mL qualitative application): N = 40 samples
- Accuracy (2000 ng/mL quantitative application): N = 42 samples
- Data Provenance: Not explicitly stated, but the submission is from Roche Diagnostic Systems, Inc. in the USA. Given the context of a 510(k) submission for an in vitro diagnostic device, the data is likely from retrospective or prospective studies conducted by the manufacturer, but this is not specified.
3. Number of Experts and their Qualifications for Ground Truth
Not applicable. The study utilized Gas Chromatography/Mass Spectrometry (GC/MS) as the reference method for establishing ground truth, not human experts.
4. Adjudication Method for the Test Set
Not applicable, as human expert adjudication was not used. GC/MS served as the objective reference method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an in vitro diagnostic device, and its performance is evaluated against a reference method (GC/MS) rather than through comparison of human reader performance with and without AI assistance.
6. Standalone Performance
Yes, a standalone performance study was conducted. The tables provided (Table 3) detail the performance characteristics of the Abuscreen OnLine II for Opiates 300/2000 Reagent independently, comparing its results directly with GC/MS. This evaluates the algorithm's performance without a human-in-the-loop component for result interpretation.
7. Type of Ground Truth Used
The ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS). For in vitro diagnostic tests, especially for drug detection, GC/MS is considered the gold standard for analytical accuracy.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set. This information is typically not included in these types of summary documents for in vitro diagnostic devices, as the focus is on validation performance against a reference method.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly state how the ground truth for any training set was established. However, given that GC/MS was used for test set validation, it is highly probable that similar laboratory methods, likely GC/MS, would have been used to establish ground truth for any internal training or development datasets.
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APR 2 4 1998
Image /page/0/Picture/3 description: The image shows the Roche logo. The logo consists of the word "Roche" written in bold, sans-serif font. The word is enclosed in a hexagon shape with rounded corners. The logo is black and white.
510(k) Summary
Abuscreen OnLine II for Opiates 300/2000 Reagent Abuscreen OnLine Opiates Calibration Pack Abuscreen OnLine Opiates Control Pack
In accordance with the Sufe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.
12974842 The assigned 510(k) number is :_
I. Identification of 510(k) Sponsor:
Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jetsey 08876-3771
510(k) Submission dated December 23, 1997
Contact: James W. Haynes Regulatory Affairs Associate Phone: (908) 253-7569 Fax: (908) 253-7547
Roche Diagnostic Systems, Inc.
Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
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Roche Diagnostic Systems, Inc. Somerville, NJ אַפּל 1998 April
Abuscreen OnLine II Opiates 300/2000 Reagent, Calibrator & Controls Summary
II. Device Name:
The device name, including both the trade/proprietary name and the classification name are provided in the table below.
Table I
| Proprietary Name | Classification Name | Product Code | Regulation Number |
|---|---|---|---|
| Abuscreen OnLine II for Opiates300/2000 Reagent | Opiate testsystem | DJG | 862.3650 |
| Abuscreen OnLine OpiatesCalibration Pack | Clinical toxicology calibrator | DLJ | 862.3200 |
| Abuscreen OnLine Opiates ControlPack | Clinical toxicology controlmaterial | DIF | 862.3280 |
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.
| Product Name | Predicate Product Name | K number | Date ofsubstantialequivalence |
|---|---|---|---|
| Abuscreen OnLine II for Opiates300/2000 Reagent | Abuscreen OnLine for Opiates | K951319 | 8/2/95 |
| Abuscreen OnLine Opiates CalibrationPack | Abuscreen ONLINE MiL Cal Pack | K935550 | 1/3/94 |
| Abuscreen OnLine Opiates ControlPack | Abuscreen OnLine Controls | K962280 | 8/16/96 |
| 1S | 17111 | 1œ11V1 | 0 |
|---|---|---|---|
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Roche Diagnostic Systems, Inc. Somerville, NJ April 1998
Description of the Device/Statement of Intended Use: IV.
Abuscreen OnLine II for Opiates 300/2000 Reagent:
The Abuscreen OnLine II for Opiates 300/2000 Reagent is an in vitro diagnostic test for the qualitative (at 300 and 2000 ug/mL cutoff) and serni-quantitative (at 2000 ng/mL cutoff) detection of morphine and its metabolites in human urine.
Abuscreen OnLine Opiates Calibration Pack:
The Abuscreen ONLINE Opiates Calibration Pack is an in vitro diagnostic device designed for the calibration of the Roche reagent assays for opiates.
Abuscreen ONLINE Opiates Control Pack:
The Roche Abuscreen ONLINE Opiates Control Pack is an assayed quality control sample for use with the Roche assays for opiates.
The intended use, clinical utility and incthodology of cach device is further described in the package inserts, contained in the test specific sections of this submission.
Summary of the technological characteristics of the new device in comparison to V. those of the predicate.
Tables 3-5 outline the technological characteristics (methodologies) of cach device in comparison to those of legally marketed predicate products.
VI. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence:
Tables 3-5 demonstrate the results of clinical and nonclinical studies performed using the Abuscreen OnLine II for Opiales 300/2000 Reagent. Abuscreen OnLine Opiates Calibration Pack and the Abuscreen ONLINE Opiates Control Pack, respectively. The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in these charts. This information concludes that the performance of these devices are essentially equivalent to other legally marketed devices of a similar kind.
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Roche Diagnostic Systems, Inc. Somerville, NJ April 1998
Table 3 - Abuscreen OnLine II for Opiates 300/2000 Reagent
| Abuscreen OnLine II OpiatesReagent | Abuscreen OnLine OpiatesReagent | |
|---|---|---|
| Methodology | Kinetic interaction ofmicroparticles in a solution | Kinetic interaction ofmicroparticles in a solution |
| Sample type | urine | urine |
| Calibrator | For 300ng/mL cutoff:Abuscreen OnLine CalibratorLevel 3For 2000 ng/mL cutoff:Abuscreen OnLinc OpiatesCalibration Pack | Abuscreen OnLine CalibrationPackAbuscreen ONLINE MilCalibration Pack |
| Cutoff | Qualitative:300 and 2000 ng/mLSemi-quantitative:2000 ng/mL | Semi-quantitative:2000 ng/mL |
| Reagent(active ingredients) | 1. Ab/Microparticle reagent:Microparticles attached withopiate monoclonal antibody(mouse)in buffer2. Conjugate reagent:Opiate conjugated derivativein buffer | 1. Ab reagent: Opiatemonoclonal antibody in buffer2. Microparticle reagent:Conjugated opiate derivativemicroparticles in buffer3. Diluent |
| Performance Characteristics: With the 300 ng/mL qualitative application | ||
| Assay range | Up to 2000 ng/mL | Up to 600 ng/mL |
| Precision: | ||
| Negative reading | > 95% confidence at 80% cutoff | >95% confidence at 80% cutoff |
| Positive reading | > 95% confidence at 120% cutoff | > 95% confidence at 120% cutoff |
| Accuracy(% Agreement) | N = 40100 % vs. GC/MS | N = 49100 % vs. GC/MS |
| Sensitivity(Analytical) | < 12 ng/mL | < 5.0 ng/mL |
| Performance Characteristics: With the 2000 ng/mL quantitative application | ||
| Assay range | Up to 8000 ng/mL | Up to 4000 ng/mL |
| Precision(Within-run) | 2.2 % at 1000 ng/mL3.3 % at 1600 ng/mL2.8 % at2000 ng/mL3.8 % at 2400 ng/mL4.2 % at 4000 ng/mL | 1.7 % at 246 ng/mL1.7 % at 297 ng/mL0.7 % at 359 ng/mL |
| Accuracy(% Agreement) | N = 42100 % vs. GC/MS | N = 49100 % vs. GC/MS |
| Sensitivity(Analytical) | < 12 ng/mL | < 5.0 ng/mL |
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Roche Diagnostic Systems, Inc. Somerville, NJ April 1998
Abuscreen OnLine II Opiates 300/2000 Reagent, Calibrator & Controls Summary
Table 3 - (Cont.')
| Table 4 - Abuscreen OnLine Opiates Culibration Pack | |||
|---|---|---|---|
| ----------------------------------------------------- | -- | -- | -- |
| Abuscreen ONLINE OpiatesCalibration Pack | Current AbuscreenONLINE MiL Cal Pack | |
|---|---|---|
| Matrix | human urine | human urine |
| Constituents | morphine HCL | morphine sulfate |
| Calibrator Values:ng/mL | 0 | 0 |
| 600 | 1000 | |
| 1000 | 2000 | |
| 2000 | 4000 | |
| 4000 | ||
| 8000 |
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Roche Diagnostic Systems, Inc. Somerville, NJ April 1998
| Abuscreen ONLINEOpiates Control Pack | Abuscreen ONLINEControls | |||
|---|---|---|---|---|
| Negative | Positive | Negative | Positive | |
| Matrix | humanurine | humanurine | human urine | human urine |
| Drugs: | ng/mL | ng/mL | ng/mL | ng/mL |
| Amphetamines | 500 | 1500 | ||
| Barbiturates | 100 | 300 | ||
| Benzodiazepines | 50 | 150 | ||
| Cannabinoids | 20 | 75 | ||
| Cocaine | 150 | 450 | ||
| Methadone | 150 | 450 | ||
| Methaqualone | 150 | 450 | ||
| Opiates (Morphine) | 1000 | 3000 | 150 | 450 |
| PCP | 12.5 | 38 | ||
| Propoxyphene | 150 | 450 |
Table 5 - Abuscreen OnLine Opiates Control Pack
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Image /page/6/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle-like symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the emblem. The emblem itself consists of three stylized lines forming the shape of a bird or wing.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 4 1998
James W. Haynes Requlatory Affairs Associate Roche Diagnostics Systems, Inc. 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
K974840 Re : Abuscreen OnLine II for Opiates 300/2000 Reagent, Calibration Pack and Control Pack II - - - - - - -Regulatory Class: Product Code: DJG, DJG, DJJ, DLR Dated: April 3, 1998 April 6, 1998 Received:
Dear Mr. Haynes:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
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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Page 1 _of 1
510(k) Number (if known)
Device Name: Abuscreen OnLine II for Opiates 300/2000 Abuscreen OnLine Opiates Calibration Pack Abuscreen OnLine Opiates Control Pack
Indications for Use:
The Abuscreen OnLine II for Opiates 300/2000 Reagent is an in vitro diagnostic test for the qualitative (at 300 and 2000 ng/mL cutoff) and semi-quantitative (at 2000 ng/mL cutoff) detection of morphine and its metabolites in human urine.
The Abuscreen ONLINE Opiates Calibration Pack is an in vitro diagnostic device designed for the calibration of the Roche reagent assays for opiates.
The Roche Abuscreen ONLINE Opiates Control Pack is an assayed quality control sample for use with the Roche assays for opiates.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
ﺼﺎ، ﻓ
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division:
Division:
510(k) Number: K974840
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).