(20 days)
No
The document describes a calibrator for in vitro diagnostic tests, which is a chemical reagent product, and contains no mention of AI or ML technology.
No
The device is described as an "in vitro diagnostic product intended for the calibration of methods packages," not for direct treatment or therapy.
No
Explanation: This device is a calibrator, which is used to calibrate diagnostic devices. It is not a diagnostic device itself as it does not directly diagnose a condition or disease.
No
The device description explicitly states it is a "liquid bovine serum-based product" and a "kit consists of ten vials," indicating it is a physical, in vitro diagnostic product, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The very first sentence explicitly states, "The Dimension ®Drug Calibrator II is an in vitro diagnostic product intended for the calibration of the following methods packages..." This is the most direct indicator.
- Device Description: While the description of the product itself (liquid bovine serum-based) doesn't inherently make it an IVD, it describes a reagent used in laboratory testing, which is typical for IVDs.
- Predicate Device: The mention of a predicate device (K891093; aca® Digitoxin Calibrator) which is also a calibrator for a drug assay strongly suggests that this device falls under the same regulatory category as its predicate, which is an IVD.
The other sections being "Not Found" (like image processing, AI, anatomical site, etc.) are not relevant to determining if a device is an IVD. IVDs are a broad category and don't necessarily involve these technologies or specific patient characteristics.
N/A
Intended Use / Indications for Use
The Dimension ®Drug Calibrator II is an in vitro diagnostic product intended for the calibration of the following methods packages in Flex™ reagent cartridges: Acetominophen (ACTM) Carbamazepine (CRBM) Digitoxin (DGTX) Gentamicin (GENT) Tobramycin (TOBR) Valproic Acid (VALP) Vancomycin (VANC)
Product codes
DKB
Device Description
The Dimension® Drug Calibrator II is a liquid bovine serum-based product. The kit consists of ten vials; two at each of five levels.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
aca® Digitoxin Calibrator, K891093
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
2/16/99
Dade Behring
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | Cathy P. Craft
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|--------------------------|-------------------------------------------------------------------------------|
| Date of Preparation: | January 22, 1999 |
| Name of Product: | Dimension® Drug Calibrator II |
| FDA Classification Name: | Calibrator |
| Predicate Device: | aca® Digitoxin Calibrator, K891093 |
Device Description: The Dimension® Drug Calibrator II is a liquid bovine serum-based product. The kit consists of ten vials; two at each of five levels.
Intended use: Drug Calibrator II is an in vitro diagnostic product intended for the calibration of the following methods packaged in Flex™ reagent cartridges:
Acetaminophen (ACTM) Carbamazepine (CRBM) Digitoxin (DGTX) Gentamicin (GENT) Tobramycin (TOBR) Valproic Acid (VALP) Vancomycin (VANC)
Comparison to Predicate Device:
| Item | aca® Digitoxin Calibrator | Dimension® Drug Calibrator II |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analytes | digitoxin | digitoxin, acetaminophen, |
| carbamazepine, gentamicin, | ||
| tobramycin, vancomycin | ||
| Matrix | human serum base | bovine serum base |
| Form | lyophilized | liquid |
| Volume | 3.0 mL per vial, reconstituted | 5.0 mL per vial |
| Levels | 3 levels | 5 levels |
| Digitoxin Reference | Primary standard -- | |
| USP Digitoxin | Primary standard - | |
| USP Digitoxin |
1
Comments on Substantial Equivalence: Both the aca® Digitoxin Calibrator and the Dimension® Drug Calibrator II are intended to be used as calibrators for digitoxin methods.
Conclusion: The Dimension® Drug Calibrator II is substantially equivalent to the aca® Digitoxin Calibrator based on the comparison discussed above.
C
Cathy P. Craft
ﺘﺘﺒﺮ: ﻧ 、
Regulatory Affairs and Compliance Manager Date: January 22, 1999
2
Image /page/2/Picture/1 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 an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 6 1999
Cathy P. Craft Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714
Re: K990255
Trade Name: Dimension® Drug Calibrator II Regulatory Class: II Product Code: DKB Dated: January 22, 1999 Received: January 27, 1999
Dear Ms. Craft:
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 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.
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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 vour 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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
4
Attac hment 1
Page 1 of 1
510(k) Number (if known)
Dimension @ Drug Calibrator II Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Dimension ®Drug Calibrator II is an in vitro diagnostic product intended for the calibration of the following methods packages in Flex™ reagent cartridges:
Acetominophen (ACTM) Carbamazepine (CRBM) Digitoxin (DGTX) Gentamicin (GENT) Tobramycin (TOBR) Valproic Acid (VALP) Vancomycin (VANC)
Brian Comer
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number
Cathy P. Craft Regulatory Affairs and Compliance Manager
February 9, 1999
(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