Abuscreen ONLINE BENZ 300 Calibrators are designed for the calibration of the Roche assays for Benzodiazepines. This clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Device Description

AI/ML Overview

The provided text describes a 510(k) submission for "Abuscreen ONLINE® BENZ 300 Calibrators". However, the document explicitly states: "No clinical or nonclinical tests were necessary to establish substantial equivalence."

Therefore, based on the provided text, there is no study described that proves the device meets specific acceptance criteria. The submission establishes equivalence to a predicate device ("Abuscreen ONLINE Calibration Pack," K951595) based on technological characteristics rather than performance data from a new study.

Here's a breakdown of why I cannot fulfill your request for performance data and study details:

Acceptance Criteria and Reported Device Performance: No acceptance criteria or reported device performance for the new device are mentioned in the text. The only performance-related information provided is a comparison of benzodiazepine levels (ng/mL) for calibration, which are simply the concentrations offered by the calibrators, not performance metrics.
Sample Size for Test Set and Data Provenance: Not applicable as no new test set or study was conducted.
Number of Experts and Qualifications: Not applicable.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not applicable.
Standalone Performance: Not applicable.
Type of Ground Truth: Not applicable.
Sample Size for Training Set: Not applicable.
How Ground Truth for Training Set was Established: Not applicable.

The submission focuses solely on establishing substantial equivalence to a previously cleared device by comparing characteristics like matrix, intended use, and the levels of benzodiazepines in the calibrators.

Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria (Not explicitly stated as performance criteria but as characteristics for equivalence)	Reported Device Performance (Characteristics of the new device)
Matrix	Must be urine (implied by predicate)	urine
Intended Use	For calibration of Roche assays for benzodiazepines (implied by predicate functionality for benzodiazepines)	for the calibration of Roche assays for benzodiazepines
Levels of Benzodiazepines (ng/mL)	Specific levels (0, 50, 100, 200) for calibration (from predicate)	0, 150, 300, 600

Explanation of Study (or lack thereof):

The document explicitly states in Section VI: "Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence: No clinical or nonclinical tests were necessary to establish substantial equivalence."

This means that a new study as you describe (with test sets, ground truth, expert review, etc.) was not performed for this 510(k) submission. Substantial equivalence was determined based on a comparison of the new device's characteristics (matrix, intended use, and calibration levels) with those of an already legally marketed predicate device (Abuscreen ONLINE Calibration Pack, K951595). The changes in the benzodiazepine levels (0, 150, 300, 600 ng/mL for the new device versus 0, 50, 100, 200 ng/mL for the predicate) are presented as a characteristic difference, not as a result of performance testing in this specific 510(k).

Summary

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DEC 1 5 1998

Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence appears to be 'K98355J6'. The characters are written in black ink on a white background. The handwriting is somewhat rough, and the characters are not perfectly formed.

Image /page/0/Picture/2 description: The image shows the Roche company logo. The logo consists of the word "Roche" in bold, black letters, enclosed within a black, hexagon-like shape. The shape is not a perfect hexagon, as the sides are slightly curved.

510(k) Summary

Abuscreen ONLINE® BENZ 300 Calibrators

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:________________________________________________________________________________________________________________________________________________

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 9, 1998

Contact: Maria Feijoo Manager, Regulatory Affairs Phone: (908) 253-7310 (908) 253-7547 Fax:

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 BENZ 300Calibrators	Calibrators, Drug Specific	DLJ	862.3200Class II

Tahle 1

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Identification of the legally marketed device to which the 510(k) sponsor claims III. equivalence:

The following table identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.

र11able	1
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Product Name	Predicate ProductName	510(k) Number and DatePredicate Cleared
Abuscreen ONLINE BENZ 300Calibrators	Abuscreen ONLINE CalibrationPack	K951595 9/8/95

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

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

Tables 3 outlines the characteristics of the Abuscreen ONLINE BENZ 200 Calibrators in comparison to those of legally marketed predicate products.

VI. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence:

No clinical or nonclinical tests were necessary to establish substantial equivalence.

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Comparison Summary

	Proposed:Abuscreen ONLINE BENZ300 Calibrators	Previously Cleared:(K951595)Abuscreen ONLINECalibration Pack
Matrix	urine	urine
Intended use	for the calibration of Rocheassays for benzodiazepines	for the calibration of Rocheassays for amphetamines,barbiturates,benzodiazepines, cocainemetabolite, methadone,opiates and pcp
Levels ofBenzodiazepines(ng/mL)	0150300600	050100200

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Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.

DEC 15 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Maria Feijoo Manager, Requlatory Affairs Roche Diagnostic Systems, Inc. Branchburq Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

Re: K983556 Abuscreen ONLINE® BENZ 300 Calibrators Trade Name: Requlatory Class: II Product Code: DLJ Dated: October 9, 1998 Received: October 13, 1998

Dear Ms. Feijoo:

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 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.

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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 requlation (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 Dutman

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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510(k) Number (if known)

Device Name: Abuscreen ONLINE® BENZ 300 Calibrators

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)
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	Over-The-Counter Use (Optional Format 1-2-96)
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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K983556

Regulation Number and Section

§ 862.3200 Clinical toxicology calibrator.

(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). 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.