(47 days)
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No
The document describes a calibrator for a clinical chemistry system and does not mention any AI or ML components or functionalities.
No
This device is a calibrator used to establish points of reference for measuring substances in human specimens, not for treating or diagnosing diseases.
No
Explanation: The device is a calibrator, used to establish reference points for measurements, not to directly diagnose a condition or disease. It is used on a clinical chemistry system that performs diagnostic measurements.
No
The device description explicitly states it is a "liquid, bovine serum base product" packaged in vials, indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "use on the Dade Behring Dimension® clinical chemistry system to establish points of reference that are used in determination of values in the measurement of substances in human specimens." This clearly indicates it's used to analyze human specimens in vitro (outside the body).
- Device Description: It's a "liquid, bovine serum base product" used for calibration, which is a common component of IVD systems.
- Calibration of Methods: It's used to calibrate methods for measuring substances like drugs (Acetaminophen, Carbamazepine, etc.) in human specimens. This is a core function of IVD devices.
The definition of an IVD is a device intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that definition perfectly as it's used to calibrate tests that measure substances in human specimens for medical purposes.
N/A
Intended Use / Indications for Use
The Dade Behring Dimension® Drug Calibrator II is a device intended for medical purposes for use on the Dade Behring Dimension® clinical chemistry system to establish points of reference that are used in determination of values in the measurement of substances in human specimens. The product is intended for the calibration of the following methods packaged in Dimension® Flex® reagent cartridges:
- Acetaminophen (ACTM) Carbamazepine (CRBM) Digitoxin (DGTX) Gentamicin (GENT) N-acetylprocainamide (NAPA) Procainamide (PROC) Tobramycin (TOBR) Valproic acid (VALP) Vancomycin (VANC)
Product codes (comma separated list FDA assigned to the subject device)
DKB
Device Description
The predicate Drug Calibrator II product labeling is being modified to include the assigned values for the additional N-acetylprocainamide (NAPA) and procainamide (PROC) constituents. The Dimension® Drug Calibrator II is a liquid, bovine serum base product. It is packaged as ten vials, two vials at each of five levels. Each vial contains 5.0 mL.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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K032574
Summary of Safety and Effectiveness Information
Dade Behring Dimension® Drug Calibrator II (DC49C)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR§807.92.
| Submitter's Name: | Richard M. Vaught
Dade Behring Inc.
P.O. Box 6101
Newark, DE 19714-6101 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation: | August 19, 2003 |
| Name of Product: | Dimension® Drug Calibrator II (DC49C) |
| FDA Classification Name: | Calibrator, drug mixture (91DKB) |
| Predicate Device: | Dimension® Drug Calibrator II (DC49B) [K990255]. |
| Device Description: | The predicate Drug Calibrator II product labeling is being modified to
include the assigned values for the additional N-acetylprocainamide
(NAPA) and procainamide (PROC) constituents.
The Dimension® Drug Calibrator II is a liquid, bovine serum base
product. It is packaged as ten vials, two vials at each of five levels.
Each vial contains 5.0 mL. |
| Intended Use: | The Dimension® Drug Calibrator II is an in vitro diagnostic
product intended for the calibration of the following methods
packaged in Dimension® Flex® reagent cartridges:
Acetaminophen (ACTM)
Carbamazepine (CRBM)
Digitoxin (DGTX)
Gentamicin (GENT)
N-acetylprocainamide (NAPA)
Procainamide (PROC)
Tobramycin (TOBR)
Valproic acid (VALP) |
Comparison to Predicate Device:
A summary of the features of the proposed Dade Behring Dimension® Drug Calibrator II (DC49C) product and the predicate Dimension® Drug Calibrator II product (DC49B) [K990255] is provided in the following chart:
Image /page/0/Picture/8 description: The image shows the number 000005 in a bold, sans-serif font. The numbers are black against a white background. The numbers are evenly spaced and aligned horizontally. The image is clear and easy to read.
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| Proposed
Dade Behring
Drug Calibrator II (DC49C) | | Current
Dade Behring
Drug Calibrator II (DC49B) |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | For calibration of the following
nine (9) Dimension® Flex® methods: | For calibration of the following
seven (7) Dimension® Flex® methods: |
| | Acetaminophen (ACTM)
Carbamazepine (CRBM)
Digitoxin (DGTX)
Gentamicin (GENT)
N-acetylprocainamide (NAPA)
Procainamide (PROC)
Tobramycin (TOBR)
Valproic acid (VALP)
Vancomycin (VANC) | Acetaminophen (ACTM)
Carbamazepine (CRBM)
Digitoxin (DGTX)
Gentamicin (GENT)
Tobramycin (TOBR)
Valproic acid (VALP)
Vancomycin (VANC) |
| Matrix: | Bovine serum base | Bovine serum base |
| Form: | Liquid | Liquid |
| Package: | Ten vials -five levels,
two vials/level,
5.0 mL/vial | Ten vials - five levels,
two vials/level,
5.0 mL/vial |
| Value
Assignment: | USP standards or highest-order
purity material available | USP standards or highest-order
purity material available |
Comments on Substantial Equivalence:
Both the proposed Dade Behring Dimension® Drug Calibrator II (DC49B) and the existing Dade Behring Dimension® Drug Calibrator II (DC49B) [K990255] are in vitro diagnostic products intended as calibrators for the specified Dimension® Flex® methods on Dade Behring Dimension® clinical chemistry analyzer systems.
The only difference in the product offerings is that the proposed Dimension® Drug Calibrator II (DC49C) has value assignments for the calibration of the additional Dade Behring Dimension® N-acety|procainamide (NAPA) and Procainamide (PROC) Flex® reagent cartridge methods.
Conclusion:
Based on the same design, manufacture and intended use as described above, the multianalyte, five level, bovine serum base Dimension® Drug Calibrator II products (DC49C and DC49B) are substantially equivalent. The only difference is the assigned values for the two additional analytes (procainamide and n-acetylprocainamide).
Richard M. Vaught Regulatory Affairs and Compliance Manager August 19, 2003
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other, with flowing lines above them.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT - 6 2003
Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714
Re: K032574
Trade/Device Name: Dimension® Drug Calibrator II (DC49C) Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DKB Dated: August 19, 2003 Received: August 20, 2003
Dear Mr. Vaught:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Dimension® Drug Calibrator II (DC49C) Device Name:
Indications for Use:
The Dade Behring Dimension® Drug Calibrator II is a device intended for medical purposes for use on the Dade Behring Dimension® clinical chemistry system to establish points of reference that are used in determination of values in the measurement of substances in human specimens. The product is intended for the calibration of the following methods packaged in Dimension® Flex® reagent cartridges:
- Acetaminophen (ACTM) Carbamazepine (CRBM) Digitoxin (DGTX) Gentamicin (GENT) N-acetylprocainamide (NAPA) Procainamide (PROC) Tobramycin (TOBR) Valproic acid (VALP) Vancomycin (VANC)
RmVlVaught
hard M Venoht Regulatory Affairs and Compliance Manager
August 19, 2003
(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)
Carol C Benson for Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 32574
000004