Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a standard in vitro diagnostic test kit and its use on a clinical chemistry analyzer. There is no mention of AI/ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

No.
This device is an in vitro diagnostic test used to detect propoxyphene and its metabolites in urine, which helps in the diagnosis of propoxyphene use or abuse. It does not provide therapy or treatment.

Diagnostic

Yes

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

SaMD (Software as a Medical Device)

No

The device is a test kit with reagents and is intended for use on a specific hardware analyzer, indicating it is not software-only.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic test" and that the measurements are "used in the diagnosis of propoxyphene use or abuse."
Device Description: The device is described as a "test kit" intended for use on an "automated clinical chemistry analyzer," which is a system designed for "in vitro determination."
Sample Type: The test is performed on "human urine," which is a biological sample analyzed outside of the body.

These points clearly align 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 for Propoxyphene is an in vitro diagnostic test for the qualitative and semiquantitative detection of propoxyphene and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff concentration 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 propoxyphene use or abuse.

Product codes

JXN

Device Description

Abuscreen ONLINE for Propoxyphene is an in vitro diagnostic test for the qualitative and semiquantitative detection of propoxyphene and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff concentration 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 propoxyphene use or abuse.

The proposed Abuscreen ONLINE Propoxyphene 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 Propoxyphene 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 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)

Clinical and nonclinical studies were performed using the Abuscreen ONLINE Propoxyphene test. The significant performance characteristics relied upon for a determination of substantial equivalence are summarized.

Precision Qualitative (300 ng/mL Cutoff):

Proposed:
- 95% negative at 225 ng/mL
- 95% positive at 375 ng/mL
Previously Cleared (K945195):
- 95% negative at 240 ng/mL
- 95% positive at 360 ng/mL

Precision Quantitative (300 ng/mL Cutoff):

Proposed - Within Run

150 ng/mL: Mean (ng/mL) 153, CV% 2.0
225 ng/mL: Mean (ng/mL) 239, CV% 1.3
300 ng/mL: Mean (ng/mL) 306, CV% 1.6
375 ng/mL: Mean (ng/mL) 440, CV% 1.0
450 ng/mL: Mean (ng/mL) 473, CV% 0.6

Proposed - Day-to-Day

150 ng/mL: Mean (ng/mL) 147, CV% 5.2
225 ng/mL: Mean (ng/mL) 236, CV% 3.1
300 ng/mL: Mean (ng/mL) 302, CV% 2.4
375 ng/mL: Mean (ng/mL) 435, CV% 2.4
450 ng/mL: Mean (ng/mL) 467, CV% 1.2

Previously Cleared (K945195) - Within Run

Conc. (ng/mL) 200: Mean (ng/mL) 208, CV% 3
Conc. (ng/mL) 250: Mean (ng/mL) 262, CV% 2
Conc. (ng/mL) 300: Mean (ng/mL) 292, CV% 1
Conc. (ng/mL) 340: Mean (ng/mL) 329, CV% 1

Previously Cleared (K945195) - Day-to-Day

Conc. (ng/mL) 200: Mean (ng/mL) 208, CV% 3
Conc. (ng/mL) 250: Mean (ng/mL) 262, CV% 2
Conc. (ng/mL) 300: Mean (ng/mL) 293, CV% 1
Conc. (ng/mL) 340: Mean (ng/mL) 331, CV% 1

Accuracy (300 ng/mL Cutoff):

Proposed: N=50 Confirmed Pos. (50 Pos., 0 Neg.)
Previously Cleared (K945195): N=63 Confirmed Pos. (63 Pos., 0 Neg.)

Limit of Detection:

Proposed: 0 ng/mL
Previously Cleared (K945195): 30 ng/mL

The information concludes that the performance of this device is essentially equivalent to the legally marketed predicate device.

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

Not Found

Predicate Device(s)

K945195

Reference Device(s)

K953239

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.3700 Propoxyphene test system.

(a)
Identification. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.(b)
Classification. Class II (special controls). A propoxyphene 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

DEC 1 1 1998

1983700

Roche

510(k) Summary

Abuscreen ONLINE® Propoxyphene

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:

Roche Diagnostic Systems, Inc.

Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

1

and the comments of the comments of the comments of the comments of

【】. Device Name:

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

Table 1

| Product Name | Classification Name | Product Code | CFR Number and
Regulatory Class |
|--------------------------------------|-------------------------------------|--------------|------------------------------------|
| Abuscreen ONLINE for
Propoxyphene | Enzyme Immunoassay,
Propoxyphene | JXN | 862.3700
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.

| able
C

1	V
----------------	---

| Product Name | Predicate Product
Name | 510(k) Number and Date
Predicate Cleared |
|--------------------------------------|--------------------------------------|---------------------------------------------|
| Abuscreen ONLINE for
Propoxyphene | Abuscreen ONLINE for
Propoxyphene | K945195 12/9/94 |

2

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

Abuscreen ONLINE for Propoxyphene is an in vitro diagnostic test for the qualitative and semiquantitative detection of propoxyphene and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff concentration 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 propoxyphene use or abuse.

The proposed Abuscreen ONLINE Propoxyphene 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 Propoxyphene 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 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.

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 Propoxyphene 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 Propoxyphene test. 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 Propoxyphene for Hitachi 917 Table 3

	Proposed:		Previously Cleared: (K945195)
	Abuscreen ONLINE		Abuscreen ONLINE
		Propoxyphene for Hitachi 917	Propoxyphene (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 propoxyphene and
its metabolites		qualitative and semiquantitative
detection of propoxyphene and
its metabolites
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		300 ng/mL
Reagent (active
ingredients)	1. Ab reagent: propoxyphene
polyclonal (goat) antibody in
buffer

Microparticle reagent:
Conjugated propoxyphene
derivative microparticles in
buffer
Diluent: Buffer | | 1. Ab reagent: propoxyphene
polyclonal (goat) antibody in
buffer
Microparticle reagent:
Conjugated propoxyphene
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/mL | Within Run | Mean (OD) | 150 ng/mL | 6177 | 225 ng/mL | 4247 | 300 ng/mL | 3082 | 375 ng/mL | 1710 | 450 ng/mL | 1383 | Day-to-Day | Mean (OD) | 150 ng/mL | 6015 | 225 ng/mL | 4183 | 300 ng/mL | 2988 | 375 ng/mL | 1749 | 450 ng/mL | 1433 | | Proposed: | | | | Precision Quantitative ( 300 ng/mL Cutoff ): | | Within Run | Mean (ng/mL) | 150 ng/mL | 153 | 225 ng/mL | 239 | 300 ng/mL | 306 | 375 ng/mL | 440 | 450 ng/mL | 473 | Day-to-Day | Mean (ng/mL) | 150 ng/mL | 147 | 225 ng/mL | 236 | 300 ng/mL | 302 | 375 ng/mL | 435 | 450 ng/mL | 467 | Accuracy | | 300 ng/mL Cutoff | 0 Neg. | Limit of Detection | 0 ng/mL | | >95% negative at 240 ng/mL
| | |
| CV% | | | |
| 3.8 | | | |
| 2.2 | | | |
| 3.2 | | | |
| 4.9 | | | |
| 1.6 | | | |
| CV% | | | |
| 3.3 | | | |
| 4.2 | | | |
| 3.9 | | | |
| 4.0 | | | |
| 4.7 | | | |
| | Previously Cleared: (K945195) | | |
| Abuscreen ONLINE | | Abuscreen ONLINE Propoxyphene | | |
| Propoxyphene for Hitachi 917 | | (1000 Test Kit) | |
| | | | |
| CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 2.0 | 200 | 208 | 3 |
| 1.3 | 250 | 262 | 2 |
| 1.6 | 300 | 292 | 1 |
| 1.0 | 340 | 329 | 1 |
| 0.6 | | | |
| CV% | Conc. (ng/mL) | Mean (ng/mL) | CV% |
| 5.2 | 200 | 208 | 3 |
| 3.1 | 250 | 262 | 2 |
| 2.4 | 300 | 293 | 1 |
| 2.4 | 340 | 331 | 1 |
| 1.2 | | | |
| | | | |
| N= 50 Confirmed Pos. | | N = 63 Confirmed Pos. | | |
| 50 Pos.
| | 63 Pos. 0 Neg. | | |
| | 30 ng/mL | | |

5

.. .

Abuscreen ONLINE Propoxyphene for Hitachi 917 Table 3 (Continued)

6

Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, with three curved lines above them, resembling a bird in flight.

DEC 1 1 1998

Ms. Rita Smith Senior Requlatory Affairs Associate Roche Diaqnostic 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: K983700 Abuscreen ONLINE® Propoxyphene Assay Trade Name: Requlatory Class: II Product Code: JXN 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, 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 Requlation (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 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 Sutman

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

8

Page 1 of

510(k) Number (if known)

Device Name: Abuscreen ONLINE® Propoxyphene

Indications for Use:

Abuscreen ONLINE for Propoxyphene is an in vitro diagnostic test for the qualitative and semiquantitative detection of propoxyphene and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff concentration 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 propoxyphene use or abuse.

(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-
510(k) Number K983700