Abuscreen ONLINE for Barbiturates is an in vitro diagnostic test for the qualitative and semiquantitative detection of barbiturates in human urine on the Hitachi 917 analyzer at a cutoff of 200 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 barbiturate use or abuse.

Device Description

Abuscreen ONLINE Barbiturates is an in vitro diagnostic test for the qualitative and semiquantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 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 barbiturate use or abuse. The proposed Abuscreen ONLINE Barbiturates 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 Barbiturates test kit. The labeling and packaging have been modified for use on the Hitachi 917 Analyzer as well as a modification to the buffer formulation and the 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.

AI/ML Overview

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

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance (Proposed Device)	Reported Device Performance (Predicate Device)
Precision Qualitative (200 ng/mL Cutoff):
>95% negative at 150 ng/mL	>95% negative at 150 ng/mL	>95% negative at 160 ng/mL
>95% positive at 250 ng/mL	>95% positive at 250 ng/mL	>95% positive at 240 ng/mLL
Within Run Precision (Qualitative):
100 ng/mL	Mean (OD): 3538, CV%: 2.4	Not specified
150 ng/mL	Mean (OD): 3027, CV%: 2.1	Not specified
200 ng/mL	Mean (OD): 2427, CV%: 2.0	Not specified
250 ng/mL	Mean (OD): 2138, CV%: 1.9	Not specified
300 ng/mL	Mean (OD): 1926, CV%: 1.5	Not specified
Day-to-Day Precision (Qualitative):
100 ng/mL	Mean (OD): 3602, CV%: 3.3	Not specified
150 ng/mL	Mean (OD): 3134, CV%: 3.7	Not specified
200 ng/mL	Mean (OD): 2498, CV%: 4.1	Not specified
250 ng/mL	Mean (OD): 2210, CV%: 4.1	Not specified
300 ng/mL	Mean (OD): 1992, CV%: 3.7	Not specified
Precision Quantitative (200 ng/mL):
Within Run (Quantitative):
100 ng/mL	Mean (ng/mL): 97, CV%: 3.9	Mean (ng/mL): 105, CV%: 3.7
150 ng/mL	Mean (ng/mL): 144, CV%: 3.0	Mean (ng/mL): 163, CV%: 2.5
200 ng/mL	Mean (ng/mL): 207, CV%: 2.8	Mean (ng/mL): 194, CV%: 1.5
250 ng/mL	Mean (ng/mL): 275, CV%: 1.5	Mean (ng/mL): 221, CV%: 1.8
300 ng/mL	Mean (ng/mL): 311, CV%: 1.2	Mean (ng/mL): 289, CV%: 0.8
Day-to-Day (Quantitative):
100 ng/mL	Mean (ng/mL): 98, CV%: 3.6	Mean (ng/mL): 110, CV%: 5.5
150 ng/mL	Mean (ng/mL): 144, CV%: 3.3	Mean (ng/mL): 169, CV%: 3.4
200 ng/mL	Mean (ng/mL): 203, CV%: 2.8	Mean (ng/mL): 201, CV%: 2.6
250 ng/mL	Mean (ng/mL): 270, CV%: 2.6	Mean (ng/mL): 229, CV%: 2.6
300 ng/mL	Mean (ng/mL): 309, CV%: 2.2	Mean (ng/mL): 294, CV%: 4.2
Accuracy (200 ng/mL Cutoff):	50 samples were confirmed positive, all 50 tested positive (0 negative).	74 samples were confirmed positive, all 74 tested positive (0 negative).
Limit of Detection:	2 ng/mL	20 ng/mL

Study Information:

Sample size used for the test set and the data provenance:
- Accuracy Test Set: N=50 for the proposed device (confirmed positively for barbiturates).
- Accuracy Test Set (Predicate): N=74 for the predicate device (confirmed positively for barbiturates).
- Precision Test Set: The number of runs/replicates for the precision studies (within-run and day-to-day for both qualitative and quantitative) is not explicitly stated in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The term "Confirmed Pos." is used for accuracy, implying a reference method was used to establish ground truth, but who performed it or their qualifications are not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the text.
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. This device is an in vitro diagnostic (IVD) immunoassay for detecting barbiturates in urine. It's a laboratory test, not an AI-assisted diagnostic imaging tool that would involve human readers. Therefore, an MRMC study or AI assistance is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This refers to the performance of the device itself (the immunoassay on the Hitachi 917 analyzer). The data presented in "Table 3" (Proposed column) is the standalone performance of the device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For accuracy, the ground truth was established by "Confirmed Pos." This strongly suggests a confirmatory analytical method (e.g., GC/MS) for the presence of barbiturates, rather than expert clinical consensus or pathology, as is common for drug screening tests.
The sample size for the training set:
- This information is not provided as this is an immunoassay kit (chemical reagents and method), not a machine learning algorithm that requires a "training set" in the traditional sense. The development of such assays involves formulation, calibration, and optimization, not a data-driven training process.
How the ground truth for the training set was established:
- Not applicable, as there isn't a "training set" in the context of an immunoassay kit for machine learning. The "ground truth" for calibrators would be established through precise analytical methods to create known concentrations.

Summary

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

4/3/95

483698

Image /page/0/Picture/2 description: The image shows the word "Roche" inside of a hexagon. The word is written in a simple, sans-serif font. The hexagon is outlined in black.

510(k) Summary

Abuscreen ONLINE® Barbiturates

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: K983698

I. Identification of 510(k) Sponsor:

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

Roche Diagnostic Systems, Inc.

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.

'ableT
------------	--

Product Name	ClassificationName	ProductCode	CFRNumber andRegulatory Class
Abuscreen ONLINE forBarbiturates	Enzyme Immunoassay,Barbiturate	DIS	862.3150Class 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	(
T	2

Product Name	Predicate ProductName	510(k) Number and DatePredicate Cleared
Abuscreen ONLINE forBarbiturates	Abuscreen ONLINE forBarbiturates	K914468 10/30/91

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

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

The proposed Abuscreen ONLINE Barbiturates 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 Barbiturates test kit. The labeling and packaging have been modified for use on the Hitachi 917 Analyzer as well as a modification to the buffer formulation and the 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 Barbiturates 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 Barbiturates 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 Barbiturates for Hitachi 917 Table 3

	Proposed:		Previously Cleared: (K914468)
	Abuscreen ONLINE Barbiturates		Abuscreen ONLINE Barbiturates(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 barbiturates		qualitative detection ofbarbiturates
Calibrator	Abuscreen ONLINE CalibrationPack or Abuscreen ONLINECalibrator Level 3		Abuscreen ONLINE CalibrationPack or Abuscreen ONLINECalibrator Level 3
Cutoff(s)	200 ng/mL		200 ng/mL
Reagent (activeingredients)	1. Ab reagent: secobarbitalpolyclonal (sheep) antibody inbuffer2. Microparticle reagent:Conjugated secobarbitalderivative microparticles inbuffer3. Diluent: Buffer		1. Ab reagent: secobarbitalpolyclonal (sheep) antibody inbuffer2. Microparticle reagent:Conjugated secobarbitalderivative microparticles inbuffer3. Diluent: Buffer
Performance Characteristics:
Precision Qualitative (200 ng/mL Cutoff):
	>95% negative at 150 ng/mL>95% positive at 250 ng/mL		>95% negative at 160 ng/mL>95% positive at 240 ng/mLL
Within Run	Mean (OD)	CV%
100 ng/mL	3538	2.4
150 ng/mL	3027	2.1
200 ng/mL	2427	2.0
250 ng/mL	2138	1.9
300 ng/mL	1926	1.5
Day-to-Day	Mean (OD)	CV%
100 ng/mL	3602	3.3
150 ng/mL	3134	3.7
200 ng/mL	2498	4.1
250 ng/mL	2210	4.1
300 ng/mL	1992	3.7
	Proposed:		Previously Cleared: (K914468)
	Abuscreen ONLINE		Abuscreen ONLINE Barbiturates
	Barbiturates for Hitachi 917		(1000 Test Kit)
Precision Quantitative (200 ng/mL):
Within Run	Mean (ng/mL)	CV%	Mean (ng/mL)	CV%
100 ng/mL	97	3.9	105	3.7
150 ng/mL	144	3.0	163	2.5
200 ng/mL	207	2.8	194	1.5
250 ng/mL	275	1.5	221	1.8
300 ng/mL	311	1.2	289	0.8
Day-to-Day	Mean (ng/mL)	CV%	Mean (ng/mL)	CV%
100 ng/mL	98	3.6	110	5.5
150 ng/mL	144	3.3	169	3.4
200 ng/mL	203	2.8	201	2.6
250 ng/mL	270	2.6	229	2.6
300 ng/mL	309	2.2	294	4.2
Accuracy
200 ng/mL Cutoff	N= 50 Confirmed Pos.		N = 74 Confirmed Pos.
	50 Pos.0 Neg.		74 Pos. 0 Neg.
Limit of Detection	2 ng/mL		20 ng/mL

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

Abuscreen ONLINE Barbiturates for Hitachi 917 Table 3 (Continued)

.27

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 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 three human profiles facing to the right. The profiles are arranged in a way that they appear to be connected. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

3 1999 MAY

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K983698

Trade Name: Abuscreen ONLINE® Barbiturates Regulatory Class: II Product Code: DIS Dated: March 23, 1999 Received: March 24, 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 (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 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.

{7}------------------------------------------------

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 Putman

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 1 of of 1

510(k) Number (if known): K983698

Device Name: Abuscreen ONLINE® Barbiturates

Indications for Use:

Lucin Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices 510(k) Number____ K 983698

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

✓

scription Use

Prescription Use (Per 21 CFR 801.109) OR

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

Regulation Number and Section

§ 862.3150 Barbiturate test system.

(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).