(112 days)
No
The summary describes a standard in vitro diagnostic test kit and an automated clinical chemistry analyzer. There is no mention of AI or ML in the device description, intended use, or performance studies. The analyzer is described as "computer-controlled" but this is typical for modern lab equipment and does not imply AI/ML.
No
This device is an in vitro diagnostic test used to detect phencyclidine in urine for diagnostic purposes, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis of phencyclidine use or abuse."
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 document explicitly states "Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test..." and describes its use for the "qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine." It also mentions that the measurements are used in the "diagnosis of phencyclidine use or abuse." These phrases are clear indicators of an in vitro diagnostic device.
- Device Description: The description reiterates that it is an "in vitro diagnostic test" and details its function in analyzing human urine samples.
- Performance Studies: The document describes clinical and nonclinical tests performed to assess the device's performance, which is typical for IVD devices undergoing regulatory review.
N/A
Intended Use / Indications for Use
Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on the Hitachi 917 analyzer at a cutoff concentration of 25 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 phencyclidine use or abuse.
Product codes
LCM
Device Description
Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff concentration of 25 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 phencyclidine use or abuse.
The proposed Abuscreen ONLINE Phencyclidine 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 Phencyclidine 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 testprocessing. 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
Clinical and nonclinical tests were performed using the Abuscreen ONLINE Phencyclidine. The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in Table 3.
- Methodology: Kinetic interaction of microparticles in a solution as measured by changes in light transmission.
- Sample type: urine
- Intended Use: qualitative and semiquantitative detection of phencyclidine and its metabolites
- Calibrator: Abuscreen ONLINE Calibration Pack or Abuscreen ONLINE Calibrator Level 3
- Cutoff(s): 25 ng/mL
Performance Characteristics:
Precision Qualitative (25 ng/mL Cutoff):
-
95% negative at 18.75 ng/mL
-
95% positive at 31.25 ng/mL
Within Run:
- 12.5 ng/mL: Mean (OD) 7842, CV% 2.9
- 18.75 ng/mL: Mean (OD) 6858, CV% 3.3
- 25.0 ng/mL: Mean (OD) 5655, CV% 1.8
- 31.25 ng/mL: Mean (OD) 4525, CV% 2.0
- 37.5 ng/mL: Mean (OD) 3732, CV% 1.2
Day-to-Day:
- 12.5 ng/mL: Mean (OD) 7516, CV% 3.3
- 18.75 ng/mL: Mean (OD) 6595, CV% 4.8
- 25.0 ng/mL: Mean (OD) 5385, CV% 3.5
- 31.25 ng/mL: Mean (OD) 4402, CV% 3.3
- 37.5 ng/mL: Mean (OD) 3622, CV% 3.1
Precision Quantitative (25 ng/mL Cutoff):
Within Run:
- 12.5 ng/mL: Mean (ng/mL) 12.1, CV% 6.2
- 18.75 ng/mL: Mean (ng/mL) 15.7, CV% 4.3
- 25.0 ng/mL: Mean (ng/mL) 25.6, CV% 2.0
- 31.25 ng/mL: Mean (ng/mL) 30.8, CV% 2.1
- 37.5 ng/mL: Mean (ng/mL) 37.6, CV% 1.9
Day-to-Day:
- 12.5 ng/mL: Mean (ng/mL) 12.4, CV% 8.6
- 18.75 ng/mL: Mean (ng/mL) 16.2, CV% 6.6
- 25.0 ng/mL: Mean (ng/mL) 25.3, CV% 5.0
- 31.25 ng/mL: Mean (ng/mL) 29.7, CV% 4.0
- 37.5 ng/mL: Mean (ng/mL) 36.3, CV% 3.4
Accuracy (25 ng/mL Cutoff):
- N= 50 Confirmed Pos.: 50 Pos. 0 Neg.
- N= 14 diluted within 25% above cutoff concentration: 14 Pos. 0 Neg.
- N= 14 diluted within 25% below cutoff concentration: 0 Pos. 14 Neg.
Limit of Detection:
- 0.6 ng/mL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
- N= 50 Confirmed Pos.: 50 Pos. 0 Neg.
- N= 14 diluted within 25% above cutoff concentration: 14 Pos. 0 Neg.
- N= 14 diluted within 25% below cutoff concentration: 0 Pos. 14 Neg.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7415 Abnormal hemoglobin assay.
(a)
Identification. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.(b)
Classification. Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
2/10/99
Roche
510(k) Summary
Abuscreen ONLINE® Phencyclidine
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: K983704
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 (908) 253-7547 Fax:
Roche Diagnostic Systems, Inc.
Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
12
1
Device Name: II.
The device name, including both the trade/proprietary name and the classification name are provided in the table below.
Table 1
| Product Name | Classification
Name | Product
Code | CFR
Number and
Regulatory Class |
|---------------------------------------|--------------------------------------|-----------------|---------------------------------------|
| Abuscreen ONLINE for
Phencyclidine | Enzyme Immunoassay,
Phencyclidine | LCM | not
available |
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.
Table 2
| Product Name | Predicate Product Name | 510(k) Number and Date
Predicate Cleared |
|---------------------------------------|---------------------------------------|---------------------------------------------|
| Abuscreen ONLINE for
Phencyclidine | Abuscreen ONLINE for
Phencyclidine | K920935 3/18/92 |
�
2
Description of the Device/Statement of Intended Use: IV.
Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff concentration of 25 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 phencyclidine use or abuse.
The proposed Abuscreen ONLINE Phencyclidine 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 Phencyclidine 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 testprocessing. 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 Phencyclidine in comparison to those of the legally marketed product.
. ".
3
15
... ..........................................................................................................................................................................
VI. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence:
Tables 3 demonstrates the results of clinical and nonclinical studies performed using the Abuscreen ONLINE Phencyclidine. 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 Phencyclidine for Hitachi 917 Table 3
| Proposed: | Previously Cleared: (K920935) | |||
|---|---|---|---|---|
| Abuscreen ONLINE | Abuscreen ONLINE | |||
| Phencyclidine for Hitachi 917 | Phencyclidine (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 phencyclidine and | ||||
| its metabolites | qualitative detection of | |||
| phencyclidine and its | ||||
| metabolites | ||||
| Calibrator | Abuscreen ONLINE Calibration | |||
| Pack or Abuscreen ONLINE | ||||
| Calibrator Level 3 | Abuscreen ONLINE Calibration | |||
| Pack or Abuscreen ONLINE | ||||
| Calibrator Level 3 | ||||
| Cutoff(s) | 25 ng/mL | 25 ng/mL | ||
| Reagent (active | ||||
| ingredients) | 1. Ab reagent: phencyclidine | |||
| monoclonal (mouse) antibody in | ||||
| buffer |
- Microparticle reagent:
Conjugated phencyclidine
derivative microparticles in
buffer - Diluent: Buffer | | 1. Ab reagent: phencyclidine
monoclonal (mouse) antibody in
buffer - Microparticle reagent:
Conjugated phencyclidine
derivative microparticles in
buffer - Diluent: Buffer | |
| Performance Characteristics: | | | | |
| Precision Qualitative ( 25 ng/mL Cutoff ): | >95% negative at 18.75 ng/mL
95% positive at 31.25 ng/mL | | >95% negative at 20 ng/mL
95% positive at 30 ng/mL | |
| | Mean (OD) | CV% | | |
| Within Run | | | | |
| 12.5 ng/mL | 7842 | 2.9 | | |
| 18.75 ng/mL | 6858 | 3.3 | | |
| 25.0 ng/mL | 5655 | 1.8 | | |
| 31.25 ng/mL | 4525 | 2.0 | | |
| 37.5 ng/mL | 3732 | 1.2 | | |
| Day-to-Day | Mean (OD) | CV% | | |
| 12.5 ng/mL | 7516 | 3.3 | | |
| 18.75 ng/mL | 6595 | 4.8 | | |
| 25.0 ng/mL | 5385 | 3.5 | | |
| 31.25 ng/mL | 4402 | 3.3 | | |
| 37.5 ng/mL | 3622 | 3.1 | | |
5
Abuscreen ONLINE Phencyclidine for Hitachi 917 Table 3 (Continued)
| Proposed: | Previously Cleared: (K920935) | ||||
|---|---|---|---|---|---|
| Abuscreen ONLINE | Abuscreen ONLINE Phencyclidine | ||||
| Phencyclidine for Hitachi 917 | (1000 Test Kit) | ||||
| Precision Quantitative ( 25 ng/mL Cutoff ): | |||||
| Within Run | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 12.5 ng/mL | 12.1 | 6.2 | 12.5 | 12 | 7 |
| 18.75 ng/mL | 15.7 | 4.3 | 18.75 | 19 | 6 |
| 25.0 ng/mL | 25.6 | 2.0 | 25.0 | 24 | 3 |
| 31.25 ng/mL | 30.8 | 2.1 | 31.25 | 27 | 3 |
| 37.5 ng/mL | 37.6 | 1.9 | |||
| Day-to-Day | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 12.5 ng/mL | 12.4 | 8.6 | 12.5 | 12 | 10 |
| 18.75 ng/mL | 16.2 | 6.6 | 18.75 | 19 | 5 |
| 25.0 ng/mL | 25.3 | 5.0 | 25.0 | 24 | 3 |
| 31.25 ng/mL | 29.7 | 4.0 | 31.25 | 27 | 3 |
| 37.5 ng/mL | 36.3 | 3.4 | |||
| Accuracy | |||||
| 25 ng/mL Cutoff | N= 50 Confirmed Pos. | ||||
| 50 Pos. 0 Neg. | N = 75 Confirmed Pos. | ||||
| 75 Pos. 0 Neg. | |||||
| N= 14 diluted within 25% | |||||
| above cutoff concentration | |||||
| 14 Pos. 0 Neg. | |||||
| N= 14 diluted within 25% | |||||
| below cutoff concentration | |||||
| 0 Pos. 14 Neg. | |||||
| Limit of Detection | 0.6 ng/mL | 6 ng/mL (clinical sensitivity) |
. . .
. .
6
Public Health Service
FEB 1 0 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: K983704 Trade Name: Abuscreen ONLINE Phencyclidine Regulatory Class: II Product Code: JCM Dated: January 14, 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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/6/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
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 Autman
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)
Device Name: Abuscreen ONLINE® Phencyclidine
Indications for Use:
Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on the Hitachi 917 analyzer at a cutoff concentration of 25 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 phencyclidine use or abuse.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983704
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
✓
Prescription Use
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)