Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on the Hitachi 917 analyzer at a cutoff concentration of 25 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 phencyclidine use or abuse.

Device Description

Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff concentration of 25 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 phencyclidine use or abuse.

The proposed Abuscreen ONLINE Phencyclidine 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 Phencyclidine 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 testprocessing. 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

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Proposed for Hitachi 917)	Reported Device Performance (Abuscreen ONLINE Phencyclidine for Hitachi 917)	Predicate Device Performance (Abuscreen ONLINE Phencyclidine K920935)
Precision Qualitative	>95% negative at 18.75 ng/mL>95% positive at 31.25 ng/mL	>95% negative at 18.75 ng/mL>95% positive at 31.25 ng/mL	>95% negative at 20 ng/mL>95% positive at 30 ng/mL
Precision (Within Run) - OD (CV%)	Not explicitly stated as acceptance criteria, but reported values are compared to predicate.	12.5 ng/mL: 2.9%18.75 ng/mL: 3.3%25.0 ng/mL: 1.8%31.25 ng/mL: 2.0%37.5 ng/mL: 1.2%	Not provided in terms of individual CVs for predicate, only qualitative stated.
Precision (Day-to-Day) - OD (CV%)	Not explicitly stated as acceptance criteria, but reported values are compared to predicate.	12.5 ng/mL: 3.3%18.75 ng/mL: 4.8%25.0 ng/mL: 3.5%31.25 ng/mL: 3.3%37.5 ng/mL: 3.1%	Not provided in terms of individual CVs for predicate, only qualitative stated.
Precision (Within Run) - Quantitative (CV%)	Not explicitly stated as acceptance criteria, but reported values are compared to predicate.	12.5 ng/mL: 6.2%18.75 ng/mL: 4.3%25.0 ng/mL: 2.0%31.25 ng/mL: 2.1%37.5 ng/mL: 1.9%	12.5 ng/mL: 7%18.75 ng/mL: 6%25.0 ng/mL: 3%31.25 ng/mL: 3%
Precision (Day-to-Day) - Quantitative (CV%)	Not explicitly stated as acceptance criteria, but reported values are compared to predicate.	12.5 ng/mL: 8.6%18.75 ng/mL: 6.6%25.0 ng/mL: 5.0%31.25 ng/mL: 4.0%37.5 ng/mL: 3.4%	12.5 ng/mL: 10%18.75 ng/mL: 5%25.0 ng/mL: 3%31.25 ng/mL: 3%
Accuracy (25 ng/mL Cutoff)	Not explicitly stated as a numerical acceptance criterion, but demonstrated by agreement with confirmed samples.	N=50 Confirmed Pos.: 50 Pos., 0 Neg.N=14 (25% above cutoff): 14 Pos., 0 Neg.N=14 (25% below cutoff): 0 Pos., 14 Neg.	N=75 Confirmed Pos.: 75 Pos., 0 Neg.
Limit of Detection	Comparability to predicate device.	0.6 ng/mL	6 ng/mL (clinical sensitivity)

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

Test Set Sample Size:
- Precision (Qualitative & Quantitative): The document reports "Mean (OD)" and "Mean (ng/mL)" values for various concentrations (12.5, 18.75, 25.0, 31.25, 37.5 ng/mL) under "Within Run" and "Day-to-Day" conditions. While the exact number of replicates per run/day isn't explicitly stated, the CV% values indicate multiple measurements were taken for each concentration.
- Accuracy:
  - N = 50 confirmed positive samples.
  - N = 14 samples diluted within 25% above cutoff concentration.
  - N = 14 samples diluted within 25% below cutoff concentration.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It presents the data as performance characteristics obtained from clinical and nonclinical studies.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The "Confirmed Pos." in the Accuracy section implies a confirmatory method was used, but the details of who performed this confirmation and their expertise are not given.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. This device is an in vitro diagnostic test for chemical analysis, not an imaging device requiring human reader interpretation in the same way.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, the study describes the standalone performance of the Abuscreen ONLINE Phencyclidine for Hitachi 917 device. The precision and accuracy data reflect the performance of the automated system operating independently. The "semisuantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program," indicating the automated nature of the results.

7. Type of Ground Truth Used

The ground truth for the "Accuracy" section was established by "Confirmed Pos." meaning it was likely confirmed by an independent, more definitive analytical method, although the specific method (e.g., GC/MS) is not explicitly named. It is based on analytical confirmation rather than pathology or outcome data.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. This type of device (enzyme immunoassay) is typically characterized and validated rather than trained in the machine learning sense. The data presented are for evaluating the performance of the developed assay.

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

As no training set is described for this type of device, the method for establishing ground truth for a training set is not applicable or provided. The "ground truth" in this context refers to accurately known concentrations of phencyclidine in samples used for validation and verification, which would be established through highly accurate analytical methods.

Summary

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2/10/99

K983704

Roche

510(k) Summary

Abuscreen ONLINE® Phencyclidine

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: K983704

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

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Device Name: II.

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

Table 1

Product Name	ClassificationName	ProductCode	CFRNumber andRegulatory Class
Abuscreen ONLINE forPhencyclidine	Enzyme Immunoassay,Phencyclidine	LCM	notavailable

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 DatePredicate Cleared
Abuscreen ONLINE forPhencyclidine	Abuscreen ONLINE forPhencyclidine	K920935 3/18/92

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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 Phencyclidine in comparison to those of the legally marketed product.

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... ..........................................................................................................................................................................

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 Phencyclidine. 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 Phencyclidine for Hitachi 917 Table 3

	Proposed:		Previously Cleared: (K920935)
	Abuscreen ONLINE		Abuscreen ONLINE
	Phencyclidine for Hitachi 917		Phencyclidine (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 phencyclidine andits metabolites		qualitative detection ofphencyclidine and itsmetabolites
Calibrator	Abuscreen ONLINE CalibrationPack or Abuscreen ONLINECalibrator Level 3		Abuscreen ONLINE CalibrationPack or Abuscreen ONLINECalibrator Level 3
Cutoff(s)	25 ng/mL		25 ng/mL
Reagent (activeingredients)	1. Ab reagent: phencyclidinemonoclonal (mouse) antibody inbuffer2. Microparticle reagent:Conjugated phencyclidinederivative microparticles inbuffer3. Diluent: Buffer		1. Ab reagent: phencyclidinemonoclonal (mouse) antibody inbuffer2. Microparticle reagent:Conjugated phencyclidinederivative microparticles inbuffer3. Diluent: Buffer
Performance Characteristics:
Precision Qualitative ( 25 ng/mL Cutoff ):	>95% negative at 18.75 ng/mL>95% positive at 31.25 ng/mL		>95% negative at 20 ng/mL>95% positive at 30 ng/mL
	Mean (OD)	CV%
Within Run
12.5 ng/mL	7842	2.9
18.75 ng/mL	6858	3.3
25.0 ng/mL	5655	1.8
31.25 ng/mL	4525	2.0
37.5 ng/mL	3732	1.2
Day-to-Day	Mean (OD)	CV%
12.5 ng/mL	7516	3.3
18.75 ng/mL	6595	4.8
25.0 ng/mL	5385	3.5
31.25 ng/mL	4402	3.3
37.5 ng/mL	3622	3.1

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Abuscreen ONLINE Phencyclidine for Hitachi 917 Table 3 (Continued)

	Proposed:		Previously Cleared: (K920935)
	Abuscreen ONLINE		Abuscreen ONLINE Phencyclidine
	Phencyclidine for Hitachi 917		(1000 Test Kit)
Precision Quantitative ( 25 ng/mL Cutoff ):
Within Run	Mean (ng/mL)	CV%	Conc. (ng/mL)	Mean (ng/mL)	CV%
12.5 ng/mL	12.1	6.2	12.5	12	7
18.75 ng/mL	15.7	4.3	18.75	19	6
25.0 ng/mL	25.6	2.0	25.0	24	3
31.25 ng/mL	30.8	2.1	31.25	27	3
37.5 ng/mL	37.6	1.9
Day-to-Day	Mean (ng/mL)	CV%	Conc. (ng/mL)	Mean (ng/mL)	CV%
12.5 ng/mL	12.4	8.6	12.5	12	10
18.75 ng/mL	16.2	6.6	18.75	19	5
25.0 ng/mL	25.3	5.0	25.0	24	3
31.25 ng/mL	29.7	4.0	31.25	27	3
37.5 ng/mL	36.3	3.4
Accuracy
25 ng/mL Cutoff	N= 50 Confirmed Pos.50 Pos. 0 Neg.		N = 75 Confirmed Pos.75 Pos. 0 Neg.
	N= 14 diluted within 25%above cutoff concentration14 Pos. 0 Neg.
	N= 14 diluted within 25%below cutoff concentration0 Pos. 14 Neg.
Limit of Detection	0.6 ng/mL		6 ng/mL (clinical sensitivity)

. . .

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Public Health Service

FEB 1 0 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rita Smith Senior Regulatory Affairs Associate Roche Diagnostic Systems, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

Re: K983704 Trade Name: Abuscreen ONLINE Phencyclidine Regulatory Class: II Product Code: JCM Dated: January 14, 1999 Received: January 19, 1999

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 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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.

Image /page/6/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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 Autman

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

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Page 1 of of 1

510(k) Number (if known)

Device Name: Abuscreen ONLINE® Phencyclidine

Indications for Use:

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983704

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

✓

Prescription Use

Prescription Use (Per 21 CFR 801.109) OR

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

Regulation Number and Section

§ 864.7415 Abnormal hemoglobin assay.

(a)
Identification. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.(b)
Classification. Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.