(63 days)
Not Found
No
The document describes a calibrator for a toxicology assay, which is a chemical reference standard, not a software or imaging device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or data analysis techniques associated with AI/ML.
No
The device is a calibrator used to establish points of reference for measuring substances in human specimens, not to treat or diagnose conditions.
No
Explanation: The device is described as a calibrator intended to establish points of reference for the measurement of substances in human specimens. It does not directly diagnose a condition or disease in a patient. Calibrators are used to ensure the accuracy of diagnostic tests, but they are not diagnostic devices themselves.
No
The device is described as "Calibrators" and is intended for the calibration of assays, implying a physical substance or material used for calibration, not purely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it's a "clinical toxicology calibrator" and is "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." This aligns perfectly with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
- Device Description: The device description reiterates the same intended use, further confirming its role in an in vitro diagnostic process.
- Predicate Device: The mention of a predicate device (K951595 Abuscreen ONLINE Calibration Pack) which is also a calibrator for a diagnostic assay, strongly suggests that this device falls under the same regulatory category as an IVD.
The fact that it's a calibrator for a diagnostic assay (Roche assays for Benzodiazepines) means it's an essential component of an in vitro diagnostic test system.
N/A
Intended Use / Indications for Use
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.
Product codes
DLJ
Device Description
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.
Matrix: urine.
Levels of Benzodiazepines (ng/mL): 0, 150, 300, 600
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
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Summary of Performance Studies
No clinical or nonclinical tests were necessary to establish substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 | Classification
Name | Product
Code | CFR
Number and
Regulatory Class |
|------------------------------------------|----------------------------|-----------------|---------------------------------------|
| Abuscreen ONLINE BENZ 300
Calibrators | Calibrators, Drug Specific | DLJ | 862.3200
Class II |
Tahle 1
1
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.
| र
1
1
| able | 1 |
|---|---|
| --------------------- | --- |
| Product Name | Predicate Product
Name | 510(k) Number and Date
Predicate Cleared |
|------------------------------------------|--------------------------------------|---------------------------------------------|
| Abuscreen ONLINE BENZ 300
Calibrators | Abuscreen ONLINE Calibration
Pack | K951595 9/8/95 |
IV. Description of the Device/Statement of Intended Use:
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.
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.
2
Comparison Summary
| | Proposed:
Abuscreen ONLINE BENZ
300 Calibrators | Previously Cleared:
(K951595)
Abuscreen ONLINE
Calibration Pack |
|-----------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | urine | urine |
| Intended use | for the calibration of Roche
assays for benzodiazepines | for the calibration of Roche
assays for amphetamines,
barbiturates,
benzodiazepines, cocaine
metabolite, methadone,
opiates and pcp |
| Levels of
Benzodiazepines
(ng/mL) | 0
150
300
600 | 0
50
100
200 |
3
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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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 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
5
Page 1 of __ 1 __
510(k) Number (if known)
Device Name: Abuscreen ONLINE® BENZ 300 Calibrators
Indications for Use:
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.
(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 | K983556 |