(51 days)
No
The summary describes a standard in vitro diagnostic test kit for use on an automated clinical chemistry analyzer. There is no mention of AI or ML in the device description, intended use, or performance studies. The "computer-controlled system" of the analyzer refers to standard automation, not AI/ML.
No
The device is an in vitro diagnostic test used to detect cannabinoids in human urine for diagnostic purposes, not for therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis of cannabinoid 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 description explicitly states it is an "in vitro diagnostic test" and that the measurements are used "in the diagnosis of cannabinoid use or abuse."
- Device Description: The description reiterates that it is an "in vitro diagnostic test."
- Function: The device analyzes human urine samples to detect the presence of cannabinoids, which is a classic function of an in vitro diagnostic test.
- Use with Clinical Chemistry Analyzer: It is designed to be used on automated clinical chemistry analyzers, which are instruments commonly used for in vitro diagnostic testing in clinical laboratories.
N/A
Intended Use / Indications for Use
Abuscreen ONLINE for Cannabinoids is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/mL, 50 ng/mL, and 100 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 cannabinoid use or abuse.
Product codes (comma separated list FDA assigned to the subject device)
LDJ
Device Description
Abuscreen ONLINE Cannabinoids is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids and its metabolites in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/mL, 50 ng/mL, and 100 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 cannabinoid use or abuse.
The proposed Abuscreen ONLINE Cannabinoids 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 Cannabinoids 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 throughout 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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The document discusses performance characteristics including qualitative and quantitative precision, and accuracy.
Qualitative Precision (20 ng/mL Cutoff):
-
95% negative at 15 ng/mL
-
95% positive at 25 ng/mL
- Within Run CV%: 0.9% at 15 ng/mL, 1.0% at 20 ng/mL, 1.3% at 25 ng/mL, 1.1% at 50 ng/mL, 2.0% at 60 ng/mL
- Day-to-Day CV%: 1.3% at 15 ng/mL, 1.4% at 20 ng/mL, 1.6% at 25 ng/mL, 2.2% at 50 ng/mL, 2.9% at 60 ng/mL
Qualitative Precision (50 ng/mL Cutoff):
-
95% negative at 40 ng/mL
-
95% positive at 60 ng/mL
- Within Run CV%: 2.9% at 25 ng/mL, 1.1% at 40 ng/mL, 1.5% at 50 ng/mL, 2.2% at 60 ng/mL, 1.3% at 75 ng/mL
- Day-to-Day CV%: 1.1% at 25 ng/mL, 1.4% at 40 ng/mL, 2.2% at 50 ng/mL, 2.5% at 60 ng/mL, 4.2% at 75 ng/mL
Qualitative Precision (100 ng/mL Cutoff):
-
95% negative at 80 ng/mL
-
95% positive at 120 ng/mL
- Within Run CV%: 1.4% at 50 ng/mL, 1.3% at 80 ng/mL, 1.2% at 100 ng/mL, 2.5% at 120 ng/mL, 2.9% at 150 ng/mL
- Day-to-Day CV%: 1.6% at 50 ng/mL, 1.8% at 80 ng/mL, 2.7% at 100 ng/mL, 2.7% at 120 ng/mL, 3.2% at 150 ng/mL
Quantitative Precision (20 ng/mL Cutoff):
- Within Run CV%: 5.0% at 15 ng/mL, 3.2% at 20 ng/mL, 2.9% at 25 ng/mL, 1.5% at 50 ng/mL, 1.3% at 60 ng/mL
- Day-to-Day CV%: 9.1% at 15 ng/mL, 8.5% at 20 ng/mL, 4.6% at 25 ng/mL, 3.3% at 50 ng/mL, 7.6% at 60 ng/mL
Quantitative Precision (50 ng/mL Cutoff):
- Within Run CV%: 2.9% at 25 ng/mL, 1.1% at 40 ng/mL, 1.5% at 50 ng/mL, 2.2% at 60 ng/mL, 1.3% at 75 ng/mL
- Day-to-Day CV%: 4.6% at 25 ng/mL, 4.0% at 40 ng/mL, 3.3% at 50 ng/mL, 5.8% at 60 ng/mL, 7.6% at 75 ng/mL
Quantitative Precision (100 ng/mL Cutoff):
- Within Run CV%: 2.3% at 50 ng/mL, 1.7% at 80 ng/mL, 2.0% at 100 ng/mL, 1.9% at 120 ng/mL, 1.5% at 150 ng/mL
- Day-to-Day CV%: 2.7% at 50 ng/mL, 2.6% at 80 ng/mL, 3.8% at 100 ng/mL, 3.2% at 120 ng/mL, 3.3% at 150 ng/mL
Accuracy:
- 20 ng/mL Cutoff: N=69 Confirmed Pos., 69 Pos., 0 Neg.
- 50 ng/mL Cutoff: N=69 Confirmed Pos., 53 Pos., 16 Neg.
- 100 ng/mL Cutoff: N=69 Confirmed Pos., 37 Pos., 32 Neg.
Limit of Detection: 7 ng/mL
The results of clinical and nonclinical studies indicate the performance of this device is essentially equivalent to the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics provided are related to precision (CV%) and qualitative accuracy based on positive/negative confirmations at specific cutoffs. Sensitivity and Specificity are implied by the accuracy data (e.g., at 20 ng/mL Cutoff, 69 Confirmed Positives were all detected as Positive, suggesting 100% sensitivity for this dataset, and 0 Negatives from Confirmed Positives).
- Qualitative Precision: The percentage of negative and positive results near cutoff concentrations (e.g., >95% negative at 15 ng/mL and >95% positive at 25 ng/mL for the 20 ng/mL cutoff).
- Precision (CV%): Coefficient of Variation for both within-run and day-to-day measurements, for both qualitative and quantitative data.
- Accuracy: The agreement between the device's results and confirmed positive/negative samples at different cutoff concentrations.
- 20 ng/mL Cutoff: N=69 Confirmed Positives, all 69 detected as Positive, 0 detected as Negative.
- 50 ng/mL Cutoff: N=69 Confirmed Positives, 53 detected as Positive, 16 detected as Negative.
- 100 ng/mL Cutoff: N=69 Confirmed Positives, 37 detected as Positive, 32 detected as Negative.
- Limit of Detection: 7 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.
Not Found
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
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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
Roche
Diagnos
510(k) Summary
Abuscreen ONLINE® Cannabinoids
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 (908) 253-7547 Fax:
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.
| C
1
abl
1
le
| 1 |
|---|
| ------------------------------- |
| Product Name | Classification
Name | Product
Code | CFR
Number and
Regulatory Class |
|--------------------------------------|-------------------------------------|-----------------|---------------------------------------|
| Abuscreen ONLINE for
Cannabinoids | Enzyme Immunoassay,
Cannabinoids | LDJ | 862.3870
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.
Table 2
| Product Name | Predicate Product Name | 510(k) Number and Date
Predicate Cleared |
|--------------------------------------|--------------------------------------|---------------------------------------------|
| Abuscreen ONLINE for
Cannabinoids | Abuscreen ONLINE for
Cannabinoids | K981585 5/28/98 |
2
IV. Description of the Device/Statement of Intended Use:
Abuscreen ONLINE Cannabinoids is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids and its metabolites in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/mL, 50 ng/mL, and 100 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 cannabinoid use or abuse.
The proposed Abuscreen ONLINE Cannabinoids 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 Cannabinoids 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 throughout 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 Cannabinoids in comparison to that of the legally marketed 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 Cannabinoids 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
Abuscreen ONLINE Cannabinoids for Hitachi 917 Table 1
| Proposed: | Previously Cleared: (K981585) | ||
|---|---|---|---|
| Abuscreen ONLINE | Abuscreen ONLINE | ||
| Cannabinoids for Hitachi 917 | Cannabinoids (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 cannabinoids and its | |||
| metabolites | qualitative and semiquantitative | ||
| detection of cannabinoids | |||
| Calibrator | Abuscreen ONLINE Cannabinoids | ||
| Calibration Pack | Abuscreen ONLINE Cannabinoids | ||
| Calibration Pack or Abuscreen | |||
| Cannabinoids Calibration Pack 20 | |||
| Cutoff(s) | 20, 50, 100 ng/mL | 20, 50, 100 ng/mL | |
| Reagent (active | |||
| ingredients) | 1. Ab reagent: cannabinoids | ||
| monclonal (mouse) antibody in | |||
| buffer |
- Microparticle reagent:
Conjugated cannabinoid derivative
microparticles in buffer - Diluent: Buffer | | 1. Ab reagent: cannabinoids
monclonal (mouse) antibody in
buffer - Microparticle reagent:
Conjugated cannabinoid derivative
microparticles in buffer - Diluent: Buffer |
| Performance Characteristics: | | | |
| Precision Qualitative ( 20 ng/mL Cutoff): | | | |
| | >95% negative at 15 ng/mL | | >95% negative at 15 ng/mL |
| | >95% positive at 25 ng/mL | | >95% positive at 25 ng/mL |
| Within Run | Mean (OD) | CV% | |
| 15 ng/mL | 5607 | 0.9 | |
| 20 ng/mL | 4990 | 1.0 | |
| 25 ng/mL | 4614 | 1.3 | |
| 50 ng/mL | 2660 | 1.1 | |
| 60 ng/mL | 2153 | 2.0 | |
| Day-to-Day | Mean (OD) | CV% | |
| 15 ng/mL | 5651 | 1.3 | |
| 20 ng/mL | 5054 | 1.4 | |
| 25 ng/mL | 4670 | 1.6 | |
| 50 ng/mL | 2729 | 2.2 | |
| 60 ng/mL | 2237 | 2.9 | |
5
Abuscreen ONLINE Cannabinoids for Hitachi 917 Table 1 (Continued)
| Proposed: | Previously Cleared: (K981585) | ||||
|---|---|---|---|---|---|
| Abuscreen ONLINE | Abuscreen ONLINE Cannabinoids | ||||
| Cannabinoids for Hitachi 917 | (1000 Test Kit) | ||||
| 50 ng/mLCutoff ): | |||||
| Precision Qualitative | |||||
| >95% negative at 40 ng/mL |
95% positive at 60 ng/mL | | >95% negative at 40 ng/mL
95% positive at 60 ng/mL | | |
| | | | | | |
| Within Run | Mean (OD) | CV% | | | |
| 25 ng/mL | 2403 | 2.9 | | | |
| 40 ng/mL | 1732 | 1.1 | | | |
| 50 ng/mL | 1340 | 1.5 | | | |
| 60 ng/mL | 1169 | 2.2 | | | |
| 75 ng/mL | 823 | 1.3 | | | |
| Day-to-Day | Mean (OD) | CV% | | | |
| 25 ng/mL | 2404 | 1.1 | | | |
| 40 ng/mL | 1749 | 1.4 | | | |
| 50 ng/mL | 1354 | 2.2 | | | |
| 60 ng/mL | 1177 | 2.5 | | | |
| 75 ng/mL | 824 | 4.2 | | | |
| Precision Qualitative | 100 ng/mL Cutoff ): | | | | |
| | >95% negative at 80 ng/mL | | >95% negative at 75 ng/mL | | |
| | >95% positive at 120 ng/mL | | | >95% positive at 125 ng/mLL | |
| Within Run | Mean (OD) | CV% | | | |
| 50 ng/mL | 3180 | 1.4 | | | |
| 80 ng/mL | 2469 | 1.3 | | | |
| 100 ng/mL | 1755 | 1.2 | | | |
| 120 ng/mL | 1547 | 2.5 | | | |
| 150 ng/mL | 1120 | 2.9 | | | |
| Day-to-Day | Mean (OD) | CV% | | | |
| 50 ng/mL | 3194 | 1.6 | | | |
| 80 ng/mL | 2483 | 1.8 | | | |
| 100 ng/mL | 1764 | 2.7 | | | |
| 120 ng/mL | 1536 | 2.7 | | | |
| 150 ng/mL | 1119 | 3.2 | | | |
| Precision Quantitative | ( 20 ng/mL Cutoff ): | | | | |
| Within Run | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 15 ng/mL | 13 | 5.0 | 15 | 13 | 6 |
| 20 ng/mL | 20 | 3.2 | 20 | 19 | 7 |
| 25 ng/mL | 23 | 2.9 | 25 | 23 | 4 |
| 50 ng/mL | 50 | 1.5 | 40 | 40 | 2 |
| 60 ng/mL | 94 | 1.3 | | | |
| Proposed:
Abuscreen ONLINE
Cannabinoids for Hitachi 917 | | | Previously Cleared: (K981585)
Abuscreen ONLINE Cannabinoids (1000 Test Kit) | | |
| Precision Quantitative (20 ng/mL Cutoff ): | | | | | |
| Day-to-Day | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 15 ng/mL | 14 | 9.1 | 15 | 14 | 7 |
| 20 ng/mL | 18 | 8.5 | 20 | 20 | 6 |
| 25 ng/mL | 24 | 4.6 | 25 | 25 | 5 |
| 50 ng/mL | 48 | 3.3 | 40 | 41 | 2 |
| 60 ng/mL | 97 | 7.6 | | | |
| Precision Quantitative ( 50 ng/mL Cutoff ): | | | | | |
| Within Run | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 25 ng/mL | 23 | 2.9 | 25 | 23 | 4 |
| 40 ng/mL | 39 | 1.1 | 40 | 40 | 2 |
| 50 ng/mL | 50 | 1.5 | 50 | 49 | 1 |
| 60 ng/mL | 62 | 2.2 | 60 | 66 | 3 |
| 75 ng/mL | 94 | 1.3 | 100 | 101 | 1 |
| Day-to-Day | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 25 ng/mL | 24 | 4.6 | 25 | 25 | 5 |
| 40 ng/mL | 39 | 4.0 | 40 | 41 | 2 |
| 50 ng/mL | 48 | 3.3 | 50 | 50 | 3 |
| 60 ng/mL | 60 | 5.8 | 60 | 68 | 3 |
| 75 ng/mL | 97 | 7.6 | 100 | 100 | 1 |
| Precision Quantitative ( 100 ng/mL Cutoff ): | | | | | |
| Within Run | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 50 ng/mL | 54 | 2.3 | 50 | 50 | 4 |
| 80 ng/mL | 74 | 1.7 | 80 | 75 | 4 |
| 100 ng/mL | 103 | 2.0 | 100 | 95 | 2 |
| 120 ng/mL | 118 | 1.9 | 120 | 123 | 2 |
| 150 ng/mL | 154 | 1.5 | 150 | 148 | 1 |
| Day-to-Day | Mean (ng/mL) | CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 50 ng/mL | 53 | 2.7 | 50 | 52 | 6 |
| 80 ng/mL | 75 | 2.6 | 80 | 76 | 3 |
| 100 ng/mL | 106 | 3.8 | 100 | 96 | 2 |
| 120 ng/mL | 120 | 3.2 | 120 | 125 | 2 |
| 150 ng/mL | 154 | 3.3 | 150 | 149 | 1 |
| Accuracy | | | | | |
| 20 ng/mL Cutoff | N= 69 Confirmed Pos.
69 Pos. 0 Neg. | | N= 50 Confirmed Pos.
50 Pos. 0 Neg. | | |
| 50 ng/mL Cutoff | N= 69 Confirmed Pos.
53 Pos. 16 Neg. | | N = 50 Confirmed Pos.
38 Pos. 12 Neg. | | |
| 100 ng/mL Cutoff | N= 69 Confirmed Pos.
37 Pos. 32 Neg. | | N= 50 Confirmed Pos.
21 Pos. 29 Neg. | | |
| Limit of Detection | 7 ng/mL | | | |