Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a standard in vitro diagnostic test kit for a chemical analyzer, with no mention of AI or ML capabilities for data analysis or interpretation beyond standard quantitative and qualitative measurements.

Therapeutic

No.
The device is an in vitro diagnostic test for detecting cocaine metabolites in urine, used for diagnosis of cocaine use or abuse, not for treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device are used in the diagnosis of cocaine use or abuse."

SaMD (Software as a Medical Device)

No

The device is an in vitro diagnostic test kit, which includes reagents and is intended for use on a specific automated clinical chemistry analyzer (hardware). It is not solely software.

IVD (In Vitro Diagnostic)

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 cocaine use or abuse."
Device Description: The description reiterates that it is an "in vitro diagnostic test" and is intended for use on automated clinical chemistry analyzers, which are commonly used in laboratory settings for in vitro diagnostics.
Intended User/Care Setting: The intended user is listed as "laboratories," which is a typical setting for performing in vitro diagnostic tests.

The core function of the device is to analyze a biological sample (human urine) outside of the body to provide information for diagnostic purposes (diagnosing cocaine use or abuse). This aligns perfectly with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DIO

Device Description

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. 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Precision Qualitative (300 ng/mL Cutoff):

95% negative at 225 ng/mL
95% positive at 375 ng/mL

Within Run:
150 ng/mL: Mean (OD) 6245, CV% 1.3
225 ng/mL: Mean (OD) 4436, CV% 1.0
300 ng/mL: Mean (OD) 2746, CV% 1.1
375 ng/mL: Mean (OD) 1907, CV% 1.4
450 ng/mL: Mean (OD) 1708, CV% 1.9

Day-to-Day:
150 ng/mL: Mean (OD) 6178, CV% 1.7
225 ng/mL: Mean (OD) 4379, CV% 2.0
300 ng/mL: Mean (OD) 2696, CV% 2.4
375 ng/mL: Mean (OD) 1873, CV% 2.9
450 ng/mL: Mean (OD) 1661, CV% 2.5

Precision Quantitative (300 ng/mL Cutoff):
Within Run:
150 ng/mL: Mean (ng/mL) 154, CV% 1.1
225 ng/mL: Mean (ng/mL) 230, CV% 1.1
300 ng/mL: Mean (ng/mL) 301, CV% 0.9
375 ng/mL: Mean (ng/mL) 407, CV% 0.6
450 ng/mL: Mean (ng/mL) 441, CV% 0.6

Day-to-Day:
150 ng/mL: Mean (ng/mL) 150, CV% 2.9
225 ng/mL: Mean (ng/mL) 228, CV% 1.4
300 ng/mL: Mean (ng/mL) 300, CV% 1.0
375 ng/mL: Mean (ng/mL) 406, CV% 0.7
450 ng/mL: Mean (ng/mL) 441, CV% 0.7

Accuracy:
300 ng/mL Cutoff: N= 50 Confirmed Pos., 50 Pos., 0 Neg.

Limit of Detection: 26 ng/mL

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Precision qualitative and quantitative data based on OD and ng/mL readings.
Accuracy (N=50 Confirmed Pos., 50 Pos., 0 Neg.)
Limit of Detection: 26 ng/mL.

Predicate Device(s)

K933053

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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 | Classification
Name | Product
Code | CFR
Number and
Regulatory Class |
|--------------------------------------------|-----------------------------------------------------------|-----------------|---------------------------------------|
| Abuscreen ONLINE for Cocaine
Metabolite | Enzyme Immunoassay,
Cocaine and Cocaine
Metabolites | DIO | 862.3250
Class 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 Product
Name | 510(k) Number and Date
Predicate Cleared |
|--------------------------------------------|------------------------------|---------------------------------------------|
| Abuscreen ONLINE for Cocaine
Metabolite | Abuscreen ONLINE for Cocaine | K933053 8/30/93 |

2

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

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. 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 for
Hitachi 917		Abuscreen ONLINE Cocaine
(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 benzoylecgonine,
the primary metabolite of
cocaine		qualitative and semiquantitative
detection of benzoylecgonine,
the primary metabolite of
cocaine
Calibrator	Abuscreen ONLINE Calibration
Pack or Abuscreen ONLINE
Calibrator Level 3		Abuscreen ONLINE Calibration
Pack or Abuscreen ONLINE
Calibrator Level 3
Cutoff(s)	300 ng/mL		150, 300 ng/mL
Reagent (active
ingredients)	1. Ab reagent: benzoylecgonine
polyclonal (sheep) antibody in
buffer

Microparticle reagent:
Conjugated benzoylecgonine
derivative microparticles in
buffer
Diluent: Buffer | | 1. Ab reagent: benzoylecgonine
polyclonal (sheep) antibody in
buffer
Microparticle reagent:
Conjugated benzoylecgonine
derivative microparticles in
buffer
Diluent: Buffer | | |
| Performance Characteristics: | | | | | |
| Precision Qualitative (300 ng/mL Cutoff): | | | | | |
| | >95% negative at 225 ng/mL

95% positive at 375 ng/mL 95% positive at 360 ng/mLL | Within Run | Mean (OD) | 150 ng/mL | 6245 | 225 ng/mL | 4436 | 300 ng/mL | 2746 | 375 ng/mL | 1907 | 450 ng/mL | 1708 | Day-to-Day | Mean (OD) | 150 ng/mL | 6178 | 225 ng/mL | 4379 | 300 ng/mL | 2696 | 375 ng/mL | 1873 | 450 ng/mL | 1661 | Abuscreen ONLINE Cocaine
for Hitachi 917 Abuscreen ONLINE Cocaine
(1000 Test Kit) | Precision Quantitative ( 300 ng/mL Cutoff ): | | Within Run | Mean (ng/mL) | 150 ng/mL | 154 | 225 ng/mL | 230 | 300 ng/mL | 301 | 375 ng/mL | 407 | 450 ng/mL | 441 | Day-to-Day | Mean (ng/mL) | 150 ng/mL | 150 | 225 ng/mL | 228 | 300 ng/mL | 300 | 375 ng/mL | 406 | 450 ng/mL | 441 | Accuracy | | 300 ng/mL Cutoff | 0 Neg. | Limit of Detection | 26 ng/mL | | >95% negative at 240 ng/mL
| | |
| CV% | | | |
| 1.3 | | | |
| 1.0 | | | |
| 1.1 | | | |
| 1.4 | | | |
| 1.9 | | | |
| CV% | | | |
| 1.7 | | | |
| 2.0 | | | |
| 2.4 | | | |
| 2.9 | | | |
| 2.5 | | | |
| Proposed:
| | Previously Cleared: (K933052)
| | |
| | | | |
| CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 1.1 | 200 | 215 | 2 |
| 1.1 | 300 | 300 | 2 |
| 0.9 | 340 | 340 | 2 |
| 0.6 | | | |
| 0.6 | | | |
| CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 2.9 | 200 | 211 | 4 |
| 1.4 | 300 | 298 | 2 |
| 1.0 | 340 | 336 | 2 |
| 0.7 | | | |
| 0.7 | | | |
| | | | |
| N= 50 Confirmed Pos. | | N = 98 Confirmed Pos. | | |
| 50 Pos.
| | 98 Pos. 0 Neg. | | |
| |