(113 days)
No
The description focuses on the chemical assay and the automated analyzer's functions (sample handling, photometric measurement, results transmission), with no mention of AI or ML for data analysis or interpretation beyond standard clinical chemistry processing.
No.
This device is an in vitro diagnostic test used to detect benzodiazepines in urine, which aids in diagnosis and quality control, but does not provide therapy.
Yes
The "Intended Use / Indications for Use" section states: "Abuscreen ONLINE Benzodiazepines is an in vitro diagnostic test..." and "...Measurements obtained by this device are used in the diagnosis of benzodiazepine use or abuse."
No
The device is an in vitro diagnostic test kit intended for use on a specific hardware analyzer (Hitachi 917 Analyzer). It includes reagents and is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Abuscreen ONLINE Benzodiazepines is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzodiazepines in human urine..."
This statement directly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Abuscreen ONLINE Benzodiazepines is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers at cutoff concentrations of 100 ng/mL, 200 ng/mL, and 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 benzodiazepine use or abuse.
Product codes (comma separated list FDA assigned to the subject device)
JXM
Device Description
Abuscreen ONLINE Benzodiazepines is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers at cutoff concentrations of 100 ng/mL, 200 ng/mL, and 300 ng/mL. The proposed Abuscreen ONLINE Benzodiazepines 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 Benzodiazepines 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.
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
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 provides precision data for qualitative detection at 100 ng/mL, 200 ng/mL, and 300 ng/mL cutoffs, including Within Run and Day-to-Day performance with Mean (OD) and CV%. It also provides precision quantitative data at 100 ng/mL, 200 ng/mL, and 300 ng/mL cutoffs, including Within Run and Day-to-Day performance with Mean (ng/mL) and CV%.
Accuracy studies were performed:
- For 100 ng/mL Cutoff: N= 50 Confirmed Pos. yielded 50 Pos. 0 Neg.; N= 10 diluted within 25% above cutoff concentration yielded 10 Pos. 0 Neg.; N= 10 diluted within 25% below cutoff concentration yielded 0 Pos. 10 Neg.
- For 200 ng/mL Cutoff: N= 50 Confirmed Pos. yielded 50 Pos. 0 Neg.; N= 10 diluted within 25% above cutoff concentration yielded 10 Pos. 0 Neg.; N= 10 diluted within 25% below cutoff concentration yielded 0 Pos. 10 Neg.
- For 300 ng/mL Cutoff: N= 50 Confirmed Pos. yielded 50 Pos. 0 Neg.; N= 10 diluted within 25% above cutoff concentration yielded 10 Pos. 0 Neg.; N= 10 diluted within 25% below cutoff concentration yielded 0 Pos. 10 Neg.
Limit of Detection results: 100 Cutoff - 13 ng/mL; 200 Cutoff - 16 ng/mL; 300 Cutoff - 28 ng/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Qualitative Precision (100 ng/mL Cutoff):
-
95% negative at 75 ng/mL
-
95% positive at 125 ng/mL
Qualitative Precision (200 ng/mL Cutoff):
-
95% negative at 150 ng/mL
-
95% positive at 250 ng/mL
Qualitative Precision (300 ng/mL Cutoff):
-
95% negative at 225 ng/mL
-
95% positive at 375 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
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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
K 983702
Roche
510(k) Summary
Abuscreen ONLINE® Benzodiazepines
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: K983702
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 Jersey 08876-3771
510(k) Submission dated October 20, 1998
Contact: Rita Smith Senior Regulatory Affairs Associate Phone: (908) 253-7545 (908) 253-7547 Fax:
Roche Diagnostic Systems, Inc.
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 | Enzyme Immunoassay, | JXM | 862.3170 |
| Benzodiazepines | Benzodiazepine | | Class II |
Identification of the legally marketed device to which the 510(k) sponsor claims III. equivalence:
The following table identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.
| 1
4
| able | 4 |
|---|---|
| ---------------- | --- |
| Product Name | Predicate Product
Name | 510(k) Number and Date
Predicate Cleared |
|-----------------------------------------|-----------------------------------------|---------------------------------------------|
| Abuscreen ONLINE for
Benzodiazepines | Abuscreen ONLINE for
Benzodiazepines | K914509 11/1/91 |
2
Description of the Device/Statement of Intended Use: IV.
Abuscreen ONLINE Benzodiazepines is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers at cutoff concentrations of 100 ng/mL, 200 ng/mL, and 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 benzodiazepine use or abuse.
The proposed Abuscreen ONLINE Benzodiazepines 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 Benzodiazepines 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.
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 Benzodiazepines 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 Benzodiazepines test kit. 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
ଜନ୍ମ
Abuscreen ONLINE Benzodiazepines for Hitachi 917 Table 3
| Proposed: | Previously Cleared: (K914509) | |||
|---|---|---|---|---|
| Abuscreen ONLINE | Abuscreen ONLINE | |||
| Benzodiazepines for Hitachi 917 | Benzodiazepines (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 benzodiazepines | qualitative detection of | |||
| benzodiazepines | ||||
| Calibrator | Abuscreen ONLINE Calibration | |||
| Pack or Abuscreen ONLINE BENZ | ||||
| 200 Cal Pack or Abuscreen ONLINE | ||||
| BENZ 300 Cal Pack | Abuscreen ONLINE Calibration | |||
| Pack or Abuscreen ONLINE | ||||
| Calibrator Level 3 | ||||
| Cutoff(s) | 100, 200, 300 ng/mL | 100 ng/mL | ||
| Reagent (active | ||||
| ingredients) | 1. Ab reagent: benzodiazepines | |||
| polyclonal (sheep) antibody in buffer |
- Microparticle reagent:
Conjugated benzodiazepine
derivative microparticles in buffer - Diluent: Buffer | | 1. Ab reagent: benzodiazepines
polyclonal (sheep) antibody in buffer - Microparticle reagent:
Conjugated benzodiazepine
derivative microparticles in buffer - Diluent: Buffer | |
| Performance Characteristics: | | | | |
| Precision Qualitative ( 100 ng/mL Cutoff ): | | | | |
| | >95% negative at 75 ng/mL | | >95% negative at 80 ng/mL | |
| | >95% positive at 125 ng/mL | | >95% positive at 120 ng/mL | |
| Within Run | Mean (OD) | CV% | | |
| 50 ng/mL | 8511 | 2.4 | | |
| 75 ng/mL | 6728 | 2.6 | | |
| 100 ng/mL | 5504 | 2.6 | | |
| 125 ng/mL | 4401 | 1.6 | | |
| 150 ng/mL | 3641 | 1.4 | | |
| Day-to-Day | Mean (OD) | CV% | | |
| 50 ng/mL | 8553 | 2.1 | | |
| 75 ng/mL | 6732 | 2.3 | | |
| 100 ng/mL | 5510 | 2.3 | | |
| 125 ng/mL | 4352 | 1.6 | | |
| 150 ng/mL | 3571 | 2.4 | | |
| Proposed: | | Previously Cleared: (K914509) | | |
| Abuscreen ONLINE | | Abuscreen ONLINE | | |
| Benzodiazepines for Hitachi 917 | | Benzodiazepines (1000 Test Kit) | | |
| Precision Qualitative ( 200 ng/mL Cutoff ): | | | | |
| | >95% negative at 150 ng/mL | | | |
| | >95% positive at 250 ng/mL | | | |
| Within Run | Mean (OD) | CV% | | |
| 100 ng/mL | 10430 | 0.7 | | |
| 150 ng/mL | 8621 | 1.3 | | |
| 200 ng/mL | 6846 | 1.6 | | |
| 250 ng/mL | 5311 | 1.8 | | |
| 300 ng/mL | 4170 | 1.8 | | |
| Day-to-Day | Mean (OD) | CV% | | |
| 100 ng/mL | 10236 | 2.7 | | |
| 150 ng/mL | 8482 | 1.5 | | |
| 200 ng/mL | 6736 | 1.5 | | |
| 250 ng/mL | 5171 | 2.6 | | |
| 300 ng/mL | 4015 | 3.1 | | |
| 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 | 9526 | 1.7 | | |
| 225 ng/mL | 6998 | 2.6 | | |
| 300 ng/mL | 5407 | 1.9 | | |
| 375 ng/mL | 4173 | 1.3 | | |
| 450 ng/mL | 3305 | 1.2 | | |
| Day-to-Day | Mean (OD) | CV% | | |
| 150 ng/mL | 9368 | 2.2 | | |
| 225 ng/mL | 6880 | 2.7 | | |
| 300 ng/mL | 5218 | 3.1 | | |
| 375 ng/mL | 4003 | 2.9 | | |
| 450 ng/mL | 3200 | 2.4 | | |
| Precision Quantitative (100 ng/mL Cutoff ): | | | | |
| Within Run | Mean (ng/mL) | CV% | Mean (ng/mL) | CV% |
| 50 ng/mL | 51 | 2.5 | 50 | 6.9 |
| 75 ng/mL | 80 | 1.9 | 81 | 3.6 |
| 100 ng/mL | 101 | 1.0 | 94 | 3.1 |
| 125 ng/mL | 128 | 1.3 | 110 | 2.9 |
| 150 ng/mL | 149 | 1.0 | 151 | 1.7 |
| | Proposed: | | Previously Cleared: (K914509) | |
| | Abuscreen ONLINE | | Abuscreen ONLINE | |
| | Benzodiazepines for Hitachi 917 | | Benzodiazepines (1000 Test Kit) | |
| Precision Quantitative (100 ng/mL Cutoff ): | | | | |
| Day-to-Day | Mean (ng/mL) | CV% | Mean (ng/mL) | CV% |
| 50 ng/mL | 50 | 3.2 | 53 | 10.1 |
| 75 ng/mL | 80 | 2.1 | 84 | 5.0 |
| 100 ng/mL | 101 | 1.7 | 97 | 4.1 |
| 125 ng/mL | 129 | 1.6 | 112 | 3.1 |
| 150 ng/mL | 150 | 1.5 | 154 | 2.7 |
| Precision Quantitative ( 200 ng/mL Cutoff ): | | | | |
| Within Run | Mean (ng/mL) | CV% | | |
| 100 ng/mL | 96 | 4.4 | | |
| 150 ng/mL | 141 | 2.7 | | |
| 200 ng/mL | 200 | 1.9 | | |
| 250 ng/mL | 251 | 1.5 | | |
| 300 ng/mL | 315 | 1.2 | | |
| Day-to-Day | Mean (ng/mL) | CV% | | |
| 100 ng/mL | 100 | 5.3 | | |
| 150 ng/mL | 145 | 3.3 | | |
| 200 ng/mL | 205 | 2.1 | | |
| 250 ng/mL | 258 | 2.2 | | |
| 300 ng/mL | 320 | 2.0 | | |
| Precision Quantitative ( 300 ng/mL Cutoff ): | | | | |
| Within Run | Mean (ng/mL) | CV% | | |
| 150 ng/mL | 152 | 2.1 | | |
| 225 ng/mL | 224 | 1.2 | | |
| 300 ng/mL | 301 | 1.4 | | |
| 375 ng/mL | 388 | 1.1 | | |
| 450 ng/mL | 465 | 0.7 | | |
| Day-to-Day | Mean (ng/mL) | CV% | | |
| 150 ng/mL | 154 | 2.7 | | |
| 225 ng/mL | 228 | 1.8 | | |
| 300 ng/mL | 306 | 2.0 | | |
| 375 ng/mL | 394 | 1.7 | | |
| 450 ng/mL | 470 | 4.3 | | |
5
Abuscreen ONLINE Benzodiazepines for Hitachi 917 Table 3 (Continued)
6
Abuscreen ONLINE Benzodiazepines for Hitachi 917 Table 3 (Continued)
7
| Accuracy | ||
|---|---|---|
| 100 ng/mL Cutoff | N= 50 Confirmed Pos. | |
| 50 Pos. 0 Neg. | ||
| N= 10 diluted within 25% above cutoff concentration | ||
| 10 Pos. 0 Neg. | ||
| N= 10 diluted within 25% below cutoff concentration | ||
| 0 Pos. 1 0 Neg. | N= 48 Confirmed Pos. | |
| 47 Pos. 1 Neg. | ||
| 200 ng/mL Cutoff | N= 50 Confirmed Pos. | |
| 50 Pos. 0 Neg. | ||
| N= 10 diluted within 25% above cutoff concentration | ||
| 10 Pos. 0 Neg. | ||
| N= 10 diluted within 25% below cutoff concentration | ||
| 0 Pos. 1 0 Neg. | ||
| 300 ng/mL Cutoff | N= 50 Confirmed Pos. | |
| 50 Pos. 0 Neg. | ||
| N= 10 diluted within 25% above cutoff concentration | ||
| 10 Pos. 0 Neg. | ||
| N= 10 diluted within 25% below cutoff concentration | ||
| 0 Pos. 1 0 Neg. | ||
| Limit of Detection | 100 Cutoff - 13 ng/mL | |
| 200 Cutoff - 16 ng/mL | ||
| 300 Cutoff - 28 ng/mL | 61 ng/mL (clinical sensitivity) |
and the same of the same of the same and the same and the same and the same and the search and
8
FEB 1 1 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Rita Smith Senior Regulatory Affairs Associate Roche Diagnostic Systems, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
Re: K983702 Trade Name: Abuscreen ONLINE Benzodiazepine Regulatory Class: II Product Code: JXM Dated: January 18, 1999 Received: January 19, 1999
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, Drug, 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 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 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 regulation (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 action. In addition, FDA may publish further announcements 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.
Image /page/8/Picture/9 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird design.
9
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/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
10
510(k) Number (if known): K983702
Device Name: Abuscreen ONLINE® Benzodiazepines
Indications for Use:
Abuscreen ONLINE Benzodiazepines is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzodiazepines in human urine on the Hitachi 917 analyzer at cutoff concentrations of 100 ng/mL, 200 ng/mL, and 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 benzodiazepine use or abuse.
Roan Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices K983702 510(k) Number .
(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)