(194 days)
No
The description focuses on a standard in vitro diagnostic test and an automated clinical chemistry analyzer, with no mention of AI or ML capabilities.
No
This device is an in vitro diagnostic test used for the qualitative and semiquantitative detection of barbiturates in human urine, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device are used in the diagnosis of barbiturate use or abuse."
No
The device is an in vitro diagnostic test kit that 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 document explicitly states "Abuscreen ONLINE for Barbiturates is an in vitro diagnostic test..." and "Measurements obtained by this device are used in the diagnosis of barbiturate use or abuse." This directly aligns with the definition of an IVD, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description reiterates that it is "an in vitro diagnostic test for the qualitative and semiquantitative detection of barbiturates in human urine..." and mentions its use on automated clinical chemistry analyzers.
- Specimen Type: The test is performed on "human urine," which is a specimen taken from the human body.
- Purpose: The purpose is to detect barbiturates and aid in the "diagnosis of barbiturate use or abuse."
All these points clearly indicate that the Abuscreen ONLINE for Barbiturates is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Abuscreen ONLINE for Barbiturates is an in vitro diagnostic test for the qualitative and semiquantitative detection of barbiturates in human urine on the Hitachi 917 analyzer at a cutoff of 200 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 barbiturate use or abuse.
Product codes
DIS
Device Description
Abuscreen ONLINE Barbiturates is an in vitro diagnostic test for the qualitative and semiquantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 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 barbiturate use or abuse.
The proposed Abuscreen ONLINE Barbiturates 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 Barbiturates test kit. The labeling and packaging have been modified for use on the Hitachi 917 Analyzer as well as a modification to the buffer formulation and the 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
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
Tables 3 demonstrates the results of clinical and nonclinical studies performed using the Abuscreen ONLINE Barbiturates 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.
Performance Characteristics:
Precision Qualitative (200 ng/mL Cutoff):
95% negative at 150 ng/mL
95% positive at 250 ng/mL
Within Run (Proposed device):
100 ng/mL: Mean (OD) 3538, CV% 2.4
150 ng/mL: Mean (OD) 3027, CV% 2.1
200 ng/mL: Mean (OD) 2427, CV% 2.0
250 ng/mL: Mean (OD) 2138, CV% 1.9
300 ng/mL: Mean (OD) 1926, CV% 1.5
Day-to-Day (Proposed device):
100 ng/mL: Mean (OD) 3602, CV% 3.3
150 ng/mL: Mean (OD) 3134, CV% 3.7
200 ng/mL: Mean (OD) 2498, CV% 4.1
250 ng/mL: Mean (OD) 2210, CV% 4.1
300 ng/mL: Mean (OD) 1992, CV% 3.7
Precision Quantitative (200 ng/mL):
Within Run (Proposed device):
100 ng/mL: Mean (ng/mL) 97, CV% 3.9
150 ng/mL: Mean (ng/mL) 144, CV% 3.0
200 ng/mL: Mean (ng/mL) 207, CV% 2.8
250 ng/mL: Mean (ng/mL) 275, CV% 1.5
300 ng/mL: Mean (ng/mL) 311, CV% 1.2
Within Run (Previously Cleared K914468):
100 ng/mL: Mean (ng/mL) 105, CV% 3.7
150 ng/mL: Mean (ng/mL) 163, CV% 2.5
200 ng/mL: Mean (ng/mL) 194, CV% 1.5
250 ng/mL: Mean (ng/mL) 221, CV% 1.8
300 ng/mL: Mean (ng/mL) 289, CV% 0.8
Day-to-Day (Proposed device):
100 ng/mL: Mean (ng/mL) 98, CV% 3.6
150 ng/mL: Mean (ng/mL) 144, CV% 3.3
200 ng/mL: Mean (ng/mL) 203, CV% 2.8
250 ng/mL: Mean (ng/mL) 270, CV% 2.6
300 ng/mL: Mean (ng/mL) 309, CV% 2.2
Day-to-Day (Previously Cleared K914468):
100 ng/mL: Mean (ng/mL) 110, CV% 5.5
150 ng/mL: Mean (ng/mL) 169, CV% 3.4
200 ng/mL: Mean (ng/mL) 201, CV% 2.6
250 ng/mL: Mean (ng/mL) 229, CV% 2.6
300 ng/mL: Mean (ng/mL) 294, CV% 4.2
Accuracy (200 ng/mL Cutoff):
Proposed: N= 50 Confirmed Pos. (50 Pos., 0 Neg.)
Previously Cleared K914468: N = 74 Confirmed Pos. (74 Pos., 0 Neg.)
Limit of Detection:
Proposed: 2 ng/mL
Previously Cleared K914468: 20 ng/mL
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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
4/3/95
483698
Image /page/0/Picture/2 description: The image shows the word "Roche" inside of a hexagon. The word is written in a simple, sans-serif font. The hexagon is outlined in black.
510(k) Summary
Abuscreen ONLINE® Barbiturates
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: K983698
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
Rita Smith Contact: Senior Regulatory Affairs Associate Phone: (908) 253-7545 Fax: (908) 253-7547
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.
| 'able
| T | |
|---|---|
| ------------ | -- |
| Product Name | Classification
Name | Product
Code | CFR
Number and
Regulatory Class |
|--------------------------------------|------------------------------------|-----------------|---------------------------------------|
| Abuscreen ONLINE for
Barbiturates | Enzyme Immunoassay,
Barbiturate | DIS | 862.3150
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.
| 'able | ( |
|---|---|
| T | 2 |
| Product Name | Predicate Product
Name | 510(k) Number and Date
Predicate Cleared |
|--------------------------------------|--------------------------------------|---------------------------------------------|
| Abuscreen ONLINE for
Barbiturates | Abuscreen ONLINE for
Barbiturates | K914468 10/30/91 |
2
Description of the Device/Statement of Intended Use: IV.
Abuscreen ONLINE Barbiturates is an in vitro diagnostic test for the qualitative and semiquantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 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 barbiturate use or abuse.
The proposed Abuscreen ONLINE Barbiturates 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 Barbiturates test kit. The labeling and packaging have been modified for use on the Hitachi 917 Analyzer as well as a modification to the buffer formulation and the 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 Barbiturates 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 Barbiturates 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 Barbiturates for Hitachi 917 Table 3
| Proposed: | Previously Cleared: (K914468) | |||
|---|---|---|---|---|
| Abuscreen ONLINE Barbiturates | Abuscreen ONLINE Barbiturates | |||
| (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 barbiturates | qualitative detection of | |||
| barbiturates | ||||
| Calibrator | Abuscreen ONLINE Calibration | |||
| Pack or Abuscreen ONLINE | ||||
| Calibrator Level 3 | Abuscreen ONLINE Calibration | |||
| Pack or Abuscreen ONLINE | ||||
| Calibrator Level 3 | ||||
| Cutoff(s) | 200 ng/mL | 200 ng/mL | ||
| Reagent (active | ||||
| ingredients) | 1. Ab reagent: secobarbital | |||
| polyclonal (sheep) antibody in | ||||
| buffer |
- Microparticle reagent:
Conjugated secobarbital
derivative microparticles in
buffer - Diluent: Buffer | | 1. Ab reagent: secobarbital
polyclonal (sheep) antibody in
buffer - Microparticle reagent:
Conjugated secobarbital
derivative microparticles in
buffer - Diluent: Buffer | |
| Performance Characteristics: | | | | |
| Precision Qualitative (200 ng/mL Cutoff): | | | | |
| | >95% negative at 150 ng/mL
95% positive at 250 ng/mL | | >95% negative at 160 ng/mL
95% positive at 240 ng/mLL | |
| Within Run | Mean (OD) | CV% | | |
| 100 ng/mL | 3538 | 2.4 | | |
| 150 ng/mL | 3027 | 2.1 | | |
| 200 ng/mL | 2427 | 2.0 | | |
| 250 ng/mL | 2138 | 1.9 | | |
| 300 ng/mL | 1926 | 1.5 | | |
| Day-to-Day | Mean (OD) | CV% | | |
| 100 ng/mL | 3602 | 3.3 | | |
| 150 ng/mL | 3134 | 3.7 | | |
| 200 ng/mL | 2498 | 4.1 | | |
| 250 ng/mL | 2210 | 4.1 | | |
| 300 ng/mL | 1992 | 3.7 | | |
| | Proposed: | | Previously Cleared: (K914468) | |
| | Abuscreen ONLINE | | Abuscreen ONLINE Barbiturates | |
| | Barbiturates for Hitachi 917 | | (1000 Test Kit) | |
| Precision Quantitative (200 ng/mL): | | | | |
| Within Run | Mean (ng/mL) | CV% | Mean (ng/mL) | CV% |
| 100 ng/mL | 97 | 3.9 | 105 | 3.7 |
| 150 ng/mL | 144 | 3.0 | 163 | 2.5 |
| 200 ng/mL | 207 | 2.8 | 194 | 1.5 |
| 250 ng/mL | 275 | 1.5 | 221 | 1.8 |
| 300 ng/mL | 311 | 1.2 | 289 | 0.8 |
| Day-to-Day | Mean (ng/mL) | CV% | Mean (ng/mL) | CV% |
| 100 ng/mL | 98 | 3.6 | 110 | 5.5 |
| 150 ng/mL | 144 | 3.3 | 169 | 3.4 |
| 200 ng/mL | 203 | 2.8 | 201 | 2.6 |
| 250 ng/mL | 270 | 2.6 | 229 | 2.6 |
| 300 ng/mL | 309 | 2.2 | 294 | 4.2 |
| Accuracy | | | | |
| 200 ng/mL Cutoff | N= 50 Confirmed Pos. | | N = 74 Confirmed Pos. | |
| | 50 Pos.
0 Neg. | | 74 Pos. 0 Neg. | |
| Limit of Detection | 2 ng/mL | | 20 ng/mL | |
5
Abuscreen ONLINE Barbiturates for Hitachi 917 Table 3 (Continued)
.27
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 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 three human profiles facing to the right. The profiles are arranged in a way that they appear to be connected. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
3 1999 MAY
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Rita Smith Senior Regulatory 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
Re: K983698
Trade Name: Abuscreen ONLINE® Barbiturates Regulatory Class: II Product Code: DIS Dated: March 23, 1999 Received: March 24, 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.
7
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 Putman
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 1 of of 1
510(k) Number (if known): K983698
Device Name: Abuscreen ONLINE® Barbiturates
Indications for Use:
Abuscreen ONLINE for Barbiturates is an in vitro diagnostic test for the qualitative and semiquantitative detection of barbiturates in human urine on the Hitachi 917 analyzer at a cutoff of 200 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 barbiturate use or abuse.
Lucin Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices 510(k) Number____ K 983698
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
✓
scription Use
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)