Abuscreen ONLINE Cocaine Metabolite is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzoylecgonine, the primary metabolite of cocaine in human urine on automated clinical chemistry analyzers at a cutoff concentrations of 300 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 cocaine use or abuse. The proposed Abuscreen ONLINE Cocaine Metabolite 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 Cocaine Metabolite test kit. The reagent compositions are the same as the previously cleared Abuscreen ONLINE Cocaine Metabolite 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 an analysis of the provided text regarding the acceptance criteria and study for the Abuscreen ONLINE® Cocaine Metabolite device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a separate section. However, by comparing the proposed device's performance to the predicate device, we can infer that the acceptance criteria for the new device align with demonstrating substantial equivalence to the predicate, particularly in the key performance characteristics. The table below summarizes the reported performance for the new device. The implied acceptance criteria are that the new device's performance should be comparable to or better than the predicate's, considering the specified cutoff levels.

Performance Characteristic	Acceptance Criteria (Implied, based on Predicate)	Reported Device Performance (Proposed: Abuscreen ONLINE Cocaine for Hitachi 917)
Precision Qualitative (300 ng/mL Cutoff):
>95% negative at 225 ng/mL	>95% negative at 240 ng/mL	>95% negative at 225 ng/mL
>95% positive at 375 ng/mL	>95% positive at 360 ng/mLL	>95% positive at 375 ng/mL
Within Run Precision (Qualitative - OD):	Similar CV% to predicate (not explicitly stated, but implied goal is low CV%)
150 ng/mL (Mean OD, CV%)	Not explicitly stated	6245, 1.3 %
225 ng/mL (Mean OD, CV%)	Not explicitly stated	4436, 1.0 %
300 ng/mL (Mean OD, CV%)	Not explicitly stated	2746, 1.1 %
375 ng/mL (Mean OD, CV%)	Not explicitly stated	1907, 1.4 %
450 ng/mL (Mean OD, CV%)	Not explicitly stated	1708, 1.9 %
Day-to-Day Precision (Qualitative - OD):	Similar CV% to predicate
150 ng/mL (Mean OD, CV%)	Not explicitly stated	6178, 1.7 %
225 ng/mL (Mean OD, CV%)	Not explicitly stated	4379, 2.0 %
300 ng/mL (Mean OD, CV%)	Not explicitly stated	2696, 2.4 %
375 ng/mL (Mean OD, CV%)	Not explicitly stated	1873, 2.9 %
450 ng/mL (Mean OD, CV%)	Not explicitly stated	1661, 2.5 %
Precision Quantitative (300 ng/mL Cutoff):	Similar CV% to predicate (e.g., <= 4% for 150ng/mL, <= 2% for 225, 300 ng/mL)
Within Run (Conc. ng/mL, CV%):
150 ng/mL	215, 2% (for 200 ng/mL predicate)	154, 1.1%
225 ng/mL	300, 2% (for 300 ng/mL predicate)	230, 1.1%
300 ng/mL	340, 2% (for 340 ng/mL predicate)	301, 0.9%
375 ng/mL	Not explicitly stated	407, 0.6%
450 ng/mL	Not explicitly stated	441, 0.6%
Day-to-Day (Conc. ng/mL, CV%):
150 ng/mL	211, 4% (for 200 ng/mL predicate)	150, 2.9%
225 ng/mL	298, 2% (for 300 ng/mL predicate)	228, 1.4%
300 ng/mL	336, 2% (for 340 ng/mL predicate)	300, 1.0%
375 ng/mL	Not explicitly stated	406, 0.7%
450 ng/mL	Not explicitly stated	441, 0.7%
Accuracy (300 ng/mL Cutoff):	100% agreement with confirmed positives (predicate had 98 positive, 0 negative)	N=50 Confirmed Pos. -> 50 Pos., 0 Neg. (100% agreement)
Limit of Detection (LoD):	< 5 ng/mL (predicate)	26 ng/mL

2. Sample Size Used for the Test Set and Data Provenance

The document mentions a sample size for an Accuracy study:

Test Set Sample Size: N=50 Confirmed Positives for the proposed device, and N=98 Confirmed Positives for the predicate device.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's an in vitro diagnostic for urinary drug screening, it's typically performed with human urine samples in a laboratory setting. The specific source or whether it was retrospective or prospective is not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document refers to "Confirmed Positives" for the Accuracy study. This implies that the ground truth was established by confirmatory methods, likely an independent, highly accurate analytical technique (e.g., GC/MS or LC/MS). The document does not mention:

The number of experts.
The qualifications of those experts (e.g., radiologist with 10 years of experience). This is expected, as medical imaging experts are not relevant for establishing ground truth in a chemical immunoassay for drug metabolites.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving experts making decisions on the test set. The "Confirmed Positives" implies a definitive laboratory confirmation method, not a consensus or "X+Y" adjudication by human readers/interpreters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for imaging diagnostics where human readers interpret medical images. This device is an in vitro diagnostic immunoassay, not an imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies reported are standalone performance characteristics of the assay itself, demonstrating its analytical performance (precision, accuracy, limit of detection). This device is a diagnostic test kit for automated analyzers, meaning its performance is inherently "standalone" from direct human interpretation in the same way an AI algorithm for imaging would be. The "Hitachi 917 Analyzer System" is a "fully automatic, computer-controlled system," indicating the device's operation is automated without human-in-the-loop decision-making impacting the primary result.

7. The Type of Ground Truth Used

The ground truth used for the accuracy study was "Confirmed Positives." In the context of drug screening, this typically refers to confirmatory analytical methods such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS), which are considered the gold standard for identifying and quantifying drug metabolites in biological samples. The document does not provide details on which specific confirmatory method was used, but it's clearly not expert consensus, pathology, or outcomes data in the usual sense.

8. The Sample Size for the Training Set

The document does not explicitly state a "training set" sample size or describe a training process. This is common for traditional immunoassay development, which relies on chemical and biological principles rather than machine learning models that require distinct training sets. The development process typically involves optimizing reagent formulations and reaction conditions, followed by validation studies.

9. How the Ground Truth for the Training Set Was Established

As no "training set" is described in the context of machine learning, the question of how ground truth was established for it does not apply in this document. The development of such assays involves established chemical and biological methods for calibrating and validating the assay's ability to detect the target analyte.

Summary

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

Image /page/0/Picture/1 description: The image shows the word "Roche" inside of a hexagon. The hexagon is a simple line drawing. The word "Roche" is written in a simple sans-serif font.

510(k) Summary

Abuscreen ONLINE® Cocaine Metabolite

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:

DEC 1 1 1998

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 for CocaineMetabolite	Enzyme Immunoassay,Cocaine and CocaineMetabolites	DIO	862.3250Class 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.

Table 2

Product Name	Predicate ProductName	510(k) Number and DatePredicate Cleared
Abuscreen ONLINE for CocaineMetabolite	Abuscreen ONLINE for Cocaine	K933053 8/30/93

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

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

The proposed Abuscreen ONLINE Cocaine Metabolite 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 Cocaine Metabolite test kit. The reagent compositions are the same as the previously cleared Abuscreen ONLINE Cocaine Metabolite 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. Additional detailed information about the Hitachi 917 Analyzer is contained in volume II of the premarket notification (K953239) cleared on September 25, 1995.

Summary of the technological characteristics of the new device in comparison to V. those of the predicate.

Tables 3 outlines the technological characteristics (methodologies) of the Abuscreen ONLINE Cocaine Metabolite in comparison to those of the legally marketed predicate product.

{3}------------------------------------------------

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 Cocaine Metabolite 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 Cocaine Metabolite for Hitachi 917 Table 1

and the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the fi

	Proposed:		Previously Cleared: (K933053)
	Abuscreen ONLINE Cocaine forHitachi 917		Abuscreen ONLINE Cocaine(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 benzoylecgonine,the primary metabolite ofcocaine		qualitative and semiquantitativedetection of benzoylecgonine,the primary metabolite ofcocaine
Calibrator	Abuscreen ONLINE CalibrationPack or Abuscreen ONLINECalibrator Level 3		Abuscreen ONLINE CalibrationPack or Abuscreen ONLINECalibrator Level 3
Cutoff(s)	300 ng/mL		150, 300 ng/mL
Reagent (activeingredients)	1. Ab reagent: benzoylecgoninepolyclonal (sheep) antibody inbuffer2. Microparticle reagent:Conjugated benzoylecgoninederivative microparticles inbuffer3. Diluent: Buffer		1. Ab reagent: benzoylecgoninepolyclonal (sheep) antibody inbuffer2. Microparticle reagent:Conjugated benzoylecgoninederivative microparticles inbuffer3. Diluent: Buffer
Performance Characteristics:
Precision Qualitative (300 ng/mL Cutoff):
	>95% negative at 225 ng/mL>95% positive at 375 ng/mL		>95% negative at 240 ng/mL>95% positive at 360 ng/mLL
Within Run	Mean (OD)	CV%
150 ng/mL	6245	1.3
225 ng/mL	4436	1.0
300 ng/mL	2746	1.1
375 ng/mL	1907	1.4
450 ng/mL	1708	1.9
Day-to-Day	Mean (OD)	CV%
150 ng/mL	6178	1.7
225 ng/mL	4379	2.0
300 ng/mL	2696	2.4
375 ng/mL	1873	2.9
450 ng/mL	1661	2.5
	Proposed:Abuscreen ONLINE Cocainefor Hitachi 917		Previously Cleared: (K933052)Abuscreen ONLINE Cocaine(1000 Test Kit)
Precision Quantitative ( 300 ng/mL Cutoff ):
Within Run	Mean (ng/mL)	CV%	Conc. (ng/mL)	Mean (ng/mL)	CV%
150 ng/mL	154	1.1	200	215	2
225 ng/mL	230	1.1	300	300	2
300 ng/mL	301	0.9	340	340	2
375 ng/mL	407	0.6
450 ng/mL	441	0.6
Day-to-Day	Mean (ng/mL)	CV%	Conc. (ng/mL)	Mean (ng/mL)	CV%
150 ng/mL	150	2.9	200	211	4
225 ng/mL	228	1.4	300	298	2
300 ng/mL	300	1.0	340	336	2
375 ng/mL	406	0.7
450 ng/mL	441	0.7
Accuracy
300 ng/mL Cutoff	N= 50 Confirmed Pos.		N = 98 Confirmed Pos.
	50 Pos.0 Neg.		98 Pos. 0 Neg.
Limit of Detection	26 ng/mL		< 5 ng/mL

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

Abuscreen ONLINE Cocaine Metabolite for Hitachi 917 Table 1 (Continued)

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

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: K983697 Abuscreen ONLINE® Cocaine Metabolite Trade Name: Requlatory Class: II Product Code: DIO Dated: October 20, 1998 October 21, 1998 Received:

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 Requlations, 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 requlatory 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

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 Toutman

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® Cocaine Metabolite

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)

Over-The-Counter Use (Optional Format 1-2-96)

(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K983697

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).