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.

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.

AI/ML Overview

The Abuscreen ONLINE Cannabinoids device meets its acceptance criteria through various performance characteristics, primarily precision (qualitative and quantitative) and accuracy studies across different cutoff concentrations (20 ng/mL, 50 ng/mL, and 100 ng/mL).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by performing "Precision Qualitative" where >95% negative at a concentration below the cutoff and >95% positive at a concentration above the cutoff should be observed. Precision is also assessed by coefficients of variation (CV%) for both within-run and day-to-day measurements of optical density (OD) and concentration (ng/mL). Accuracy is assessed by comparing the device's qualitative results with confirmed positive samples.

Performance Characteristic	Acceptance Criteria (Implicit from Predicate/Standard Practice)	Reported Device Performance (Proposed Device)
Precision Qualitative (20 ng/mL Cutoff)
at 15 ng/mL (Negative)	>95% negative	>95% negative
at 25 ng/mL (Positive)	>95% positive	>95% positive
Within Run CV% (OD)	Low CV% (e.g., <5%)	0.9% (15ng/mL) to 2.0% (60ng/mL)
Day-to-Day CV% (OD)	Low CV% (e.g., <10%)	1.3% (15ng/mL) to 2.9% (60ng/mL)
Precision Qualitative (50 ng/mL Cutoff)
at 40 ng/mL (Negative)	>95% negative	>95% negative
at 60 ng/mL (Positive)	>95% positive	>95% positive
Within Run CV% (OD)	Low CV% (e.g., <5%)	1.1% (40ng/mL) to 2.9% (25ng/mL)
Day-to-Day CV% (OD)	Low CV% (e.g., <10%)	1.1% (25ng/mL) to 4.2% (75ng/mL)
Precision Qualitative (100 ng/mL Cutoff)
at 80 ng/mL (Negative)	>95% negative	>95% negative
at 120 ng/mL (Positive)	>95% positive	>95% positive
Within Run CV% (OD)	Low CV% (e.g., <5%)	1.2% (100ng/mL) to 2.9% (150ng/mL)
Day-to-Day CV% (OD)	Low CV% (e.g., <10%)	1.6% (50ng/mL) to 3.8% (100ng/mL)
Precision Quantitative (20 ng/mL Cutoff)
Within Run CV% (ng/mL)	Low CV% (e.g., <10%)	1.3% (60ng/mL) to 5.0% (15ng/mL)
Day-to-Day CV% (ng/mL)	Low CV% (e.g., <15%)	3.3% (50ng/mL) to 9.1% (15ng/mL)
Precision Quantitative (50 ng/mL Cutoff)
Within Run CV% (ng/mL)	Low CV% (e.g., <10%)	1.1% (40ng/mL) to 2.9% (25ng/mL)
Day-to-Day CV% (ng/mL)	Low CV% (e.g., <15%)	3.3% (50ng/mL) to 5.8% (60ng/mL)
Precision Quantitative (100 ng/mL Cutoff)
Within Run CV% (ng/mL)	Low CV% (e.g., <10%)	1.5% (150ng/mL) to 2.3% (50ng/mL)
Day-to-Day CV% (ng/mL)	Low CV% (e.g., <15%)	2.6% (80ng/mL) to 3.8% (100ng/mL)
Accuracy (20 ng/mL Cutoff)	All confirmed positives detected	N=69 Confirmed Positives, 69 Pos., 0 Neg.
Accuracy (50 ng/mL Cutoff)	All confirmed positives detected above cutoff; appropriate negatives below cutoff	N=69 Confirmed Positives, 53 Pos., 16 Neg.
Accuracy (100 ng/mL Cutoff)	All confirmed positives detected above cutoff; appropriate negatives below cutoff	N=69 Confirmed Positives, 37 Pos., 32 Neg.
Limit of Detection	Comparable to predicate or established standard	7 ng/mL

2. Sample size used for the test set and the data provenance

Test Set Sample Size:
- Accuracy: N = 69 confirmed positive samples were used across all three cutoff concentrations.
- Precision (Qualitative and Quantitative): Various concentrations (e.g., 15, 20, 25, 50, 60 ng/mL for 20 ng/mL cutoff) were tested for within-run and day-to-day precision. The exact number of replicates or runs for each concentration is not explicitly stated, but the presence of Mean (OD/ng/mL) and CV% values implies multiple measurements.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document implies that "Confirmed Positives" were used as ground truth for accuracy studies. However, the number of experts, their qualifications, or the method of confirmation are not specified in the provided text.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set. The term "Confirmed Positives" suggests a definitive reference method was used, but the process of arriving at this confirmation (e.g., 2+1, 3+1, or a single expert) is not detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is a diagnostic device for in vitro detection of cannabinoids in urine, not an imaging-based AI system requiring human interpretation or multi-reader studies. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device is an automated clinical chemistry analyzer test kit. The performance described (precision and accuracy) is inherently the standalone performance of the device (reagents and analyzer) without human-in-the-loop diagnostic interpretation in the sense of AI-assisted diagnosis. The test itself is an "algorithm only" performance, where the algorithm is the chemical reaction and photometric measurement logic of the analyzer.

7. The type of ground truth used

The ground truth for the accuracy studies was "Confirmed Positives." This implies a reference method, likely Gas Chromatography-Mass Spectrometry (GC-MS), which is typically considered the gold standard for confirming drug concentrations in toxicology. The text does not explicitly state GC-MS, but "Confirmed Positives" for drug testing generally refers to such highly accurate analytical methods.

8. The sample size for the training set

This device is an in vitro diagnostic assay, not a machine learning model that requires a "training set" in the conventional sense of AI. There is no mention of a training set for an algorithm. The development of such assays involves method validation and optimization by the manufacturer, but this is a different process than training a predictive AI model.

9. How the ground truth for the training set was established

As explained in point 8, the concept of a "training set" and associated ground truth establishment is not applicable to this type of in vitro diagnostic device.

Summary

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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

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II. Device Name:

The device name, including both the trade/proprietary name and the classification name are provided in the table below.

C1abl1le1
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Product Name	ClassificationName	ProductCode	CFRNumber andRegulatory Class
Abuscreen ONLINE forCannabinoids	Enzyme Immunoassay,Cannabinoids	LDJ	862.3870Class 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 DatePredicate Cleared
Abuscreen ONLINE forCannabinoids	Abuscreen ONLINE forCannabinoids	K981585 5/28/98

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IV. Description of the Device/Statement of Intended Use:

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.

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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.

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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 microparticlesin a solution as measured bychanges in light transmission	Kinetic interaction of microparticlesin a solution as measured bychanges in light transmission
Sample type	urine		urine
Intended Use	qualitative and semiquantitativedetection of cannabinoids and itsmetabolites		qualitative and semiquantitativedetection of cannabinoids
Calibrator		Abuscreen ONLINE CannabinoidsCalibration Pack	Abuscreen ONLINE CannabinoidsCalibration Pack or AbuscreenCannabinoids Calibration Pack 20
Cutoff(s)	20, 50, 100 ng/mL		20, 50, 100 ng/mL
Reagent (activeingredients)	1. Ab reagent: cannabinoidsmonclonal (mouse) antibody inbuffer2. Microparticle reagent:Conjugated cannabinoid derivativemicroparticles in buffer3. Diluent: Buffer		1. Ab reagent: cannabinoidsmonclonal (mouse) antibody inbuffer2. Microparticle reagent:Conjugated cannabinoid derivativemicroparticles in buffer3. 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

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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 ONLINECannabinoids 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				< 5 ng/mL

: 上一

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Abuscreen ONLINE Cannabinoids for Hitachi 917 Table 1 (Continued)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, depicted in black.

DEC 1 1 1998

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

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re : K983701 Abuscreen ONLINE® Cannabinoids Assay Trade Name: Regulatory Class: II Product Code: LDJ Dated: October 20, 1998 October 21, 1998

Dear Ms. Smith:

Received:

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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 regulatory In addition, FDA may publish further announcements concerning action. your device in the Federal Reqister. 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 requlations.

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Page 2

This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 requlation (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 Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Page of

510(k) Number (if known)

Device Name: Abuscreen ONLINE® Cannabinoids

Indications for Use:

(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)

(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K983701

Regulation Number and Section

§ 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).