Abuscreen ONLINE for Amphetamines is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine and methamphetamine and their metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 1000 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 amphetamine use or abuse.

Device Description

Abuscreen ONLINE Amphetamines is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine and methamphetamine and their metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 1000 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 amphetamine use or abuse.

The proposed Abuscreen ONLINE Amphetamines 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 Amphetamines test kit. The reagent compositions are the same as the previously cleared Abuscreen ONLINE Amphetamines kit; although the labeling and packaging have been modified for use on the Hitachi 917 Analyzer. 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Abuscreen ONLINE® Amphetamines device, based on the provided text:

Acceptance Criteria and Device Performance

Criteria	Acceptance Criteria (from Predicate Device - K933052)	Reported Device Performance (Abuscreen ONLINE for Hitachi 917)
Precision Qualitative (1000 ng/mL Cutoff):
Negative at 800 ng/mL	>95% negative	>95% negative at 750 ng/mL (Exceeds predicate)
Positive at 1500 ng/mL	>95% positive	>95% positive at 1250 ng/mL (Exceeds predicate)
Quantitative Precision (Within Run):	CV% (Predicate): 3-6%	CV% (Proposed): 0.5-1.4%
Quantitative Precision (Day-to-Day):	CV% (Predicate): 4-7%	CV% (Proposed): 1.4-3.0%
Accuracy (1000 ng/mL Cutoff):	N=156 Confirmed Pos., 155 Pos., 1 Neg.	N=50 Confirmed Pos., 50 Pos., 0 Neg.
Limit of Detection	30 ng/mL	11 ng/mL (Exceeds predicate)

Note: The document explicitly states, "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." The proposed device generally demonstrates equal or superior performance compared to the predicate.

Study Details

Sample size used for the test set and the data provenance:
- Accuracy Test Set:
  - Number of samples: N = 50 confirmed positive samples.
  - Data provenance: Not explicitly stated, but assumed to be retrospective or prospective clinical samples given the context of "confirmed positive." No country of origin is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The term "Confirmed Pos." suggests a definitive method for determining the true positive status, likely an orthogonal method like GC/MS (Gas Chromatography-Mass Spectrometry), which is common for drug screening confirmation, rather than expert consensus on images or clinical interpretation.
Adjudication method for the test set:
- Not applicable/Not described. The ground truth (confirmed positive) would be established by an analytical method rather than a human adjudication process in this diagnostic context.
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:
- No MRMC study was done. This device is an in vitro diagnostic for chemical analysis, not an imaging or interpretive device that would typically involve human readers or AI assistance in that manner.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance characteristics presented (Precision, Accuracy, LOD) are those of the device itself (reagent kit on the Hitachi 917 Analyzer), operating automatically without human interpretive input for the result generation. The device is intended for "qualitative and semiquantitative detection," which are objective measurements.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For Accuracy: "Confirmed Pos." (Confirmed Positive). This almost invariably refers to confirmation by a highly sensitive and specific analytical method, such as Gas Chromatography-Mass Spectrometry (GC/MS), which is considered the gold standard for drug confirmation testing.
- For Precision: Controlled samples with known concentrations (e.g., 500 ng/mL, 750 ng/mL, etc.) were used, making the true concentration the ground truth.
The sample size for the training set:
- Not applicable/Not explicitly stated. This device is an immunoassay, not a machine learning or AI-driven system that would typically undergo a separate "training" phase with a distinct dataset in the modern sense. Its performance is based on the chemical reactivity of its components and its integration with the analyzer. Development and optimization would have occurred, but not in the "training set" paradigm of current AI.
How the ground truth for the training set was established:
- Not applicable, as there's no explicit "training set" as understood in current AI/ML development. The "ground truth" for method development would involve preparing samples with known concentrations of drug metabolites and using reference methods (like GC/MS) to characterize unknown samples used during the development and validation of the assay's chemical and enzymatic reactions.

Summary

{0}------------------------------------------------

1983699

Roche

DEC 1 1 1998

510(k) Summary

Abuscreen ONLINE® Amphetamines

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 Fax: (908) 253-7547

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	ClassificationName	ProductCode	CFRNumber andRegulatory Class
Abuscreen ONLINE forAmphetamines	Enzyme Immunoassay,Amphetamine	DKZ	862.3100Class II

Identification of the legally marketed device to which the 510(k) sponsor claims III. equivalence:

The following table identifies the legally marketed device to which Roche Diagnostic Systems, Inc. claims equivalence. : 中国 .

Table	y
-----------	---

Product Name	Predicate Product Name	510(k) Number and DatePredicate Cleared
Abuscreen ONLINE forAmphetamines	Abuscreen ONLINE forAmphetamines	K933052 9/15/93

{2}------------------------------------------------

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

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 Amphetamines 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 Amphetamines 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 Amphetamines for Hitachi 917 Table 3

	Proposed:		Previously Cleared: (K933052)
	Abuscreen ONLINE		Abuscreen ONLINE
	Amphetamines for Hitachi 917		Amphetamines (1000 Test Kit)
Methodology	Kinetic interaction ofmicroparticles in a solution asmeasured by changes in lighttransmission		Kinetic interaction ofmicroparticles in a solution asmeasured by changes in lighttransmission
Sample type	urine		urine
Intended Use	qualitative and semiquantitativedetection of amphetamine andmethamphetamine and theirmetabolites		qualitative and semiquantitativedetection of amphetamine andmethamphetamine and theirmetabolites
Calibrator	Abuscreen ONLINE CalibrationPack or Abuscreen ONLINECalibrator Level 3		Abuscreen ONLINE CalibrationPack or Abuscreen ONLINECalibrator Level 3
Cutoff(s)	1000 ng/mL		500 and 1000 ng/mL
Reagent (activeingredients)	1. Ab reagent: amphetamineand methamphetaminemonoclonal (mouse) antibody inbuffer2. Microparticle reagent:Conjugated amphetaminederivative microparticles inbuffer3. Diluent: Buffer		1. Ab reagent: amphetamineand methamphetaminemonoclonal (mouse) antibody inbuffer2. Microparticle reagent:Conjugated amphetaminederivative microparticles inbuffer3. Diluent: Buffer
Performance Characteristics:
Precision Qualitative (1000 ng/mL Cutoff):
	>95% negative at 750 ng/mL		>95% negative at 800ng/mL
	>95% positive at 1250 ng/mL		>95% positive at 1500 ng/mL
Within Run	Mean (OD)	CV%
500 ng/mL	5117	0.5
750 ng/mL	3910	0.5
1000 ng/mL	3033	0.5
1250 ng/mL	2569	0.8
1500 ng/mL	2254	0.6
Day-to-Day	Mean (OD)	CV%
500 ng/mL	5096	1.8
750 ng/mL	3905	1.6
1000 ng/mL	3061	1.4
1250 ng/mL	2548	1.7
1500 ng/mL	2232	1.8
Proposed:		Previously Cleared: (K933052)
Abuscreen ONLINE		Abuscreen ONLINE
	Amphetamines for Hitachi 917	Amphetamines (1000 Test Kit)
Precision Quantitative (1000 ng/mL Cutoff ):
Within Run	Mean (ng/mL)	CV%	Mean (ng/mL)	CV%
500 ng/mL	508	0.7	620	6
750 ng/mL	747	0.5	834	5
1000 ng/mL	1013	1.4	973	4
1250 ng/mL	1255	1.0	1177	3
1500 ng/mL	1485	1.0
Day-to-Day	Mean (ng/mL)	CV%	Mean (ng/mL)	CV%
500 ng/mL	492	3.0	616	7
750 ng/mL	731	2.0	846	5
1000 ng/mL	1005	1.4	974	5
1250 ng/mL	1261	1.5	1181	4
1500 ng/mL	1475	1.4
Accuracy
1000 ng/mL Cutoff	N= 50 Confirmed Pos.50 Pos. 0 Neg.		N = 156 Confirmed Pos.155 Pos. 1 Neg.
Limit of Detection	11 ng/mL		30 ng/mL

{5}------------------------------------------------

Abuscreen ONLINE Amphetamines for Hitachi 917 Table 3 (Continued)

{6}------------------------------------------------

Image /page/6/Picture/2 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 an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

DEC 1 1 1998

Ms. Rita Smith Senior Requlatory 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 : K983699

Abuscreen ONLINE® Amphetamines Assay Trade Name: Requlatory Class: II Product Code: DKZ Dated: October 20, 1998 Received: October 21, 1998

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, Druq, 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 reqistration, 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 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you miqht 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

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 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 Gutman

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 ー of 1

510(k) Number (if known)

Device Name: Abuscreen ONLINE® Amphetamines

Indications for Use:

(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)

(Division Sign-Off)
Division of Clinical Laboratory Devices
Laboratory Devices 99

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).