(51 days)
No
The document describes a standard in vitro diagnostic test kit for detecting amphetamines in urine using an automated clinical chemistry analyzer. There is no mention of AI or ML in the intended use, device description, or performance studies. The automation refers to the analyzer's ability to process samples and perform measurements, not to AI/ML-driven analysis.
No
This device is an in vitro diagnostic test used for the diagnosis of amphetamine use or abuse, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis of amphetamine use or abuse." This indicates its role in identifying or determining a medical condition.
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).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in vitro diagnostic test" and is used for the "diagnosis of amphetamine use or abuse."
- Device Description: The description reiterates that it is an "in vitro diagnostic test."
- Function: It analyzes human urine samples to detect the presence of specific substances (amphetamine and methamphetamine and their metabolites) to provide information about a person's health status (amphetamine use). This is the core function of an IVD.
- Use with Clinical Chemistry Analyzers: It is designed to be used on automated clinical chemistry analyzers, which are standard equipment in clinical laboratories for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
Abuscreen ONLINE® Amphetamines is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine and methamphetamine and their metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 1000 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 amphetamine use or abuse.
Product codes (comma separated list FDA assigned to the subject device)
DKZ
Device Description
Abuscreen ONLINE Amphetamines is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine and methamphetamine and their metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 1000 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 amphetamine use or abuse.
The proposed Abuscreen ONLINE Amphetamines 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 Amphetamines test kit. The reagent compositions are the same as the previously cleared Abuscreen ONLINE Amphetamines kit; although the labeling and packaging have been modified for use on the Hitachi 917 Analyzer. 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
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. Key performance characteristics include:
- Precision Qualitative (1000 ng/mL Cutoff):
-
95% negative at 750 ng/mL
-
95% positive at 1250 ng/mL
-
- Within Run Precision Qualitative (OD): 500 ng/mL (Mean 5117, CV% 0.5), 750 ng/mL (Mean 3910, CV% 0.5), 1000 ng/mL (Mean 3033, CV% 0.5), 1250 ng/mL (Mean 2569, CV% 0.8), 1500 ng/mL (Mean 2254, CV% 0.6)
- Day-to-Day Precision Qualitative (OD): 500 ng/mL (Mean 5096, CV% 1.8), 750 ng/mL (Mean 3905, CV% 1.6), 1000 ng/mL (Mean 3061, CV% 1.4), 1250 ng/mL (Mean 2548, CV% 1.7), 1500 ng/mL (Mean 2232, CV% 1.8)
- Within Run Precision Quantitative (ng/mL): 500 ng/mL (Mean 508, CV% 0.7), 750 ng/mL (Mean 747, CV% 0.5), 1000 ng/mL (Mean 1013, CV% 1.4), 1250 ng/mL (Mean 1255, CV% 1.0), 1500 ng/mL (Mean 1485, CV% 1.0)
- Day-to-Day Precision Quantitative (ng/mL): 500 ng/mL (Mean 492, CV% 3.0), 750 ng/mL (Mean 731, CV% 2.0), 1000 ng/mL (Mean 1005, CV% 1.4), 1250 ng/mL (Mean 1261, CV% 1.5), 1500 ng/mL (Mean 1475, CV% 1.4)
- Accuracy (1000 ng/mL Cutoff): N= 50 Confirmed Pos. (50 Pos. 0 Neg.)
- Limit of Detection: 11 ng/mL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Precision: within run and day-to-day (qualitative and quantitative) for various concentrations (500, 750, 1000, 1250, 1500 ng/mL)
- Accuracy: At 1000 ng/mL cutoff, 50 confirmed positive samples yielded 50 positive results and 0 negative results.
- Limit of Detection: 11 ng/mL
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.
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
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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
1983699
Roche
DEC 1 1 1998
510(k) Summary
Abuscreen ONLINE® Amphetamines
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 Fax: (908) 253-7547
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.
| Product Name | Classification
Name | Product
Code | CFR
Number and
Regulatory Class |
|--------------------------------------|------------------------------------|-----------------|---------------------------------------|
| Abuscreen ONLINE for
Amphetamines | Enzyme Immunoassay,
Amphetamine | DKZ | 862.3100
Class II |
Identification of the legally marketed device to which the 510(k) sponsor claims III. equivalence:
The following table identifies the legally marketed device to which Roche Diagnostic Systems, Inc. claims equivalence. : 中国 .
| T
| able | y |
|---|---|
| ----------- | --- |
| Product Name | Predicate Product Name | 510(k) Number and Date
Predicate Cleared |
|--------------------------------------|--------------------------------------|---------------------------------------------|
| Abuscreen ONLINE for
Amphetamines | Abuscreen ONLINE for
Amphetamines | K933052 9/15/93 |
2
Description of the Device/Statement of Intended Use: IV.
Abuscreen ONLINE Amphetamines is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine and methamphetamine and their metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 1000 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 amphetamine use or abuse.
The proposed Abuscreen ONLINE Amphetamines 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 Amphetamines test kit. The reagent compositions are the same as the previously cleared Abuscreen ONLINE Amphetamines kit; although the labeling and packaging have been modified for use on the Hitachi 917 Analyzer. 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.
V. Summary of the technological characteristics of the new device in comparison to those of the predicate.
Tables 3 outlines the technological characteristics (methodologies) of the Abuscreen ONLINE Amphetamines test kit 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 Amphetamines test kit on the Hitachi 917 Analyzer. 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 Amphetamines for Hitachi 917 Table 3
| Proposed: | Previously Cleared: (K933052) | |||
|---|---|---|---|---|
| Abuscreen ONLINE | Abuscreen ONLINE | |||
| Amphetamines for Hitachi 917 | Amphetamines (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 amphetamine and | ||||
| methamphetamine and their | ||||
| metabolites | qualitative and semiquantitative | |||
| detection of amphetamine and | ||||
| methamphetamine and their | ||||
| metabolites | ||||
| Calibrator | Abuscreen ONLINE Calibration | |||
| Pack or Abuscreen ONLINE | ||||
| Calibrator Level 3 | Abuscreen ONLINE Calibration | |||
| Pack or Abuscreen ONLINE | ||||
| Calibrator Level 3 | ||||
| Cutoff(s) | 1000 ng/mL | 500 and 1000 ng/mL | ||
| Reagent (active | ||||
| ingredients) | 1. Ab reagent: amphetamine | |||
| and methamphetamine | ||||
| monoclonal (mouse) antibody in | ||||
| buffer |
- Microparticle reagent:
Conjugated amphetamine
derivative microparticles in
buffer - Diluent: Buffer | | 1. Ab reagent: amphetamine
and methamphetamine
monoclonal (mouse) antibody in
buffer - Microparticle reagent:
Conjugated amphetamine
derivative microparticles in
buffer - Diluent: Buffer | |
| Performance Characteristics: | | | | |
| Precision Qualitative (1000 ng/mL Cutoff): | | | | |
| | >95% negative at 750 ng/mL | | >95% negative at 800ng/mL | |
| | >95% positive at 1250 ng/mL | | >95% positive at 1500 ng/mL | |
| Within Run | Mean (OD) | CV% | | |
| 500 ng/mL | 5117 | 0.5 | | |
| 750 ng/mL | 3910 | 0.5 | | |
| 1000 ng/mL | 3033 | 0.5 | | |
| 1250 ng/mL | 2569 | 0.8 | | |
| 1500 ng/mL | 2254 | 0.6 | | |
| Day-to-Day | Mean (OD) | CV% | | |
| 500 ng/mL | 5096 | 1.8 | | |
| 750 ng/mL | 3905 | 1.6 | | |
| 1000 ng/mL | 3061 | 1.4 | | |
| 1250 ng/mL | 2548 | 1.7 | | |
| 1500 ng/mL | 2232 | 1.8 | | |
| Proposed: | | Previously Cleared: (K933052) | | |
| Abuscreen ONLINE | | Abuscreen ONLINE | | |
| | Amphetamines for Hitachi 917 | Amphetamines (1000 Test Kit) | | |
| Precision Quantitative (1000 ng/mL Cutoff ): | | | | |
| Within Run | Mean (ng/mL) | CV% | Mean (ng/mL) | CV% |
| 500 ng/mL | 508 | 0.7 | 620 | 6 |
| 750 ng/mL | 747 | 0.5 | 834 | 5 |
| 1000 ng/mL | 1013 | 1.4 | 973 | 4 |
| 1250 ng/mL | 1255 | 1.0 | 1177 | 3 |
| 1500 ng/mL | 1485 | 1.0 | | |
| Day-to-Day | Mean (ng/mL) | CV% | Mean (ng/mL) | CV% |
| 500 ng/mL | 492 | 3.0 | 616 | 7 |
| 750 ng/mL | 731 | 2.0 | 846 | 5 |
| 1000 ng/mL | 1005 | 1.4 | 974 | 5 |
| 1250 ng/mL | 1261 | 1.5 | 1181 | 4 |
| 1500 ng/mL | 1475 | 1.4 | | |
| Accuracy | | | | |
| 1000 ng/mL Cutoff | N= 50 Confirmed Pos.
50 Pos. 0 Neg. | | N = 156 Confirmed Pos.
155 Pos. 1 Neg. | |
| Limit of Detection | 11 ng/mL | | 30 ng/mL | |
5
Abuscreen ONLINE Amphetamines for Hitachi 917 Table 3 (Continued)
6
Image /page/6/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
DEC 1 1 1998
Ms. Rita Smith Senior Requlatory Affairs Associate Roche Diagnostic Systems, Inc. A Subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re : K983699
Abuscreen ONLINE® Amphetamines Assay Trade Name: Requlatory Class: II Product Code: DKZ Dated: October 20, 1998 Received: October 21, 1998
Dear Ms. Smith:
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 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, Druq, and Cosmetic Act (Act). 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 reqistration, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
7
Page 2
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 qeneral 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/dsma/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
8
Page ー of 1
510(k) Number (if known)
Device Name: Abuscreen ONLINE® Amphetamines
Indications for Use:
Abuscreen ONLINE for Amphetamines is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine and methamphetamine and their metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 1000 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 amphetamine use or abuse.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
Laboratory Devices 99