(121 days)
Not Found
No
The summary describes a standard in vitro diagnostic test for detecting opiates in urine, relying on chemical reagents and calibration/control packs. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance metrics are standard for IVD assays and do not suggest the use of AI/ML algorithms.
No
The device is an in vitro diagnostic test used for detecting substances in human urine, and calibration/control packs for these tests. It is not used for treating or diagnosing a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Abuscreen OnLine II is "an in vitro diagnostic test for the qualitative... and semi-quantitative... detection of morphine and its metabolites in human urine." It also refers to the Abuscreen ONLINE Opiates Calibration Pack as "an in vitro diagnostic device."
No
The device description clearly states it is an in vitro diagnostic test and includes reagents, calibration packs, and control packs, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The Abuscreen OnLine II for Opiates 300/2000 Reagent is an in vitro diagnostic test..."
- "The Abuscreen ONLINE Opiates Calibration Pack is an in vitro diagnostic device..."
- "The Roche Abuscreen ONLINE Opiates Control Pack is an assayed quality control sample for use with the Roche assays for opiates." (While this one doesn't explicitly say "in vitro diagnostic device," it is a component used with the in vitro diagnostic tests and calibration pack, making it part of the overall IVD system).
The "Device Description" section also reiterates that the reagent and calibration pack are "in vitro diagnostic" devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DLJ, DIF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Clinical and nonclinical studies were performed.
For Abuscreen OnLine II for Opiates 300/2000 Reagent with the 300 ng/mL qualitative application:
- Assay range: Up to 2000 ng/mL
- Precision: > 95% confidence at 80% cutoff for negative reading, > 95% confidence at 120% cutoff for positive reading.
- Accuracy (% Agreement): N = 40, 100 % vs. GC/MS
- Sensitivity (Analytical): 95% confidence at 80% cutoff (Negative reading)
- Precision: > 95% confidence at 120% cutoff (Positive reading)
- Accuracy (% Agreement): 100 % vs. GC/MS (N = 40)
- Sensitivity (Analytical):
§ 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).
0
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
1
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 Opiates | |||
| 300/2000 Reagent | Opiate test | ||
| system | DJG | 862.3650 | |
| Abuscreen OnLine Opiates | |||
| Calibration Pack | Clinical toxicology calibrator | DLJ | 862.3200 |
| Abuscreen OnLine Opiates Control | |||
| Pack | Clinical toxicology control | ||
| material | 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 of
substantial
equivalence |
|-----------------------------------------------------|-------------------------------|----------|---------------------------------------|
| Abuscreen OnLine II for Opiates
300/2000 Reagent | Abuscreen OnLine for Opiates | K951319 | 8/2/95 |
| Abuscreen OnLine Opiates Calibration
Pack | Abuscreen ONLINE MiL Cal Pack | K935550 | 1/3/94 |
| Abuscreen OnLine Opiates Control
Pack | Abuscreen OnLine Controls | K962280 | 8/16/96 |
| 1
S | 17
11
1 | 1
œ
11
V
1 | 0 |
|--------|---------------|------------------------|---|
| | | | |
2
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.
3
Roche Diagnostic Systems, Inc. Somerville, NJ April 1998
Table 3 - Abuscreen OnLine II for Opiates 300/2000 Reagent
| | Abuscreen OnLine II Opiates
Reagent | Abuscreen OnLine Opiates
Reagent |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | Kinetic interaction of
microparticles in a solution | Kinetic interaction of
microparticles in a solution |
| Sample type | urine | urine |
| Calibrator | For 300ng/mL cutoff:
Abuscreen OnLine Calibrator
Level 3
For 2000 ng/mL cutoff:
Abuscreen OnLinc Opiates
Calibration Pack | Abuscreen OnLine Calibration
Pack
Abuscreen ONLINE Mil
Calibration Pack |
| Cutoff | Qualitative:
300 and 2000 ng/mL
Semi-quantitative:
2000 ng/mL | Semi-quantitative:
2000 ng/mL |
| Reagent
(active ingredients) | 1. Ab/Microparticle reagent:
Microparticles attached with
opiate monoclonal antibody
(mouse)in buffer
2. Conjugate reagent:
Opiate conjugated derivative
in buffer | 1. Ab reagent: Opiate
monoclonal antibody in buffer
2. Microparticle reagent:
Conjugated opiate derivative
microparticles in buffer
3. 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 = 40
100 % vs. GC/MS | N = 49
100 % vs. GC/MS |
| Sensitivity
(Analytical) |