(20 days)
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)
The Dimension® Drug Calibrator II is a liquid bovine serum-based product. The kit consists of ten vials; two at each of five levels.
The provided document is a 510(k) premarket notification for a medical device called "Dimension® Drug Calibrator II". It describes the device's intended use and compares it to a predicate device ("aca® Digitoxin Calibrator") to establish substantial equivalence.
However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically found for AI/ML-based medical devices or diagnostic tests that have quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.).
Instead, this submission is for a calibrator, which is a reference material used to set instruments so that they can accurately measure analytes. The primary demonstration for this type of device in a 510(k) submission is typically showing substantial equivalence to an existing, legally marketed predicate device, rather than a clinical performance study with statistical metrics against a ground truth.
The "Comparison to Predicate Device" table (page 1) effectively serves as the "acceptance criteria" and "reported device performance" in the context of a substantial equivalence claim for a calibrator. The acceptance criterion is that the new device is sufficiently similar to the predicate device in key aspects such as intended use, analytes, matrix, form, volume, levels, and reference standards. The "reported device performance" is simply a description of these attributes for the new device and the predicate.
Here's an attempt to answer your questions based on the available information, noting that many items will be "Not Applicable" or "Not Provided" given the nature of a calibrator 510(k) submission:
- A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria (based on predicate) | Reported Device Performance (Dimension® Drug Calibrator II) |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analytes | Includes digitoxin | digitoxin, acetaminophen, carbamazepine, gentamicin, tobramycin, vancomycin |
| Matrix | Human serum base (for aca predicate) | Bovine serum base |
| Form | Lyophilized (for aca predicate | 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 |
| Overall Equivalence | Substantially equivalent to predicate | Deemed substantially equivalent to aca® Digitoxin Calibrator by FDA |
*Note: For a calibrator, the "acceptance criteria" are generally aligned with demonstrating that the new device performs its function as a calibrator effectively and safely, and often, without being significantly different to a predicate device regarding fundamental characteristics. The performance is assessed by comparison, not a clinical accuracy study.*
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Not Applicable / Not Provided. This document does not describe a clinical test set or data provenance in the context of device performance metrics like sensitivity or specificity. The evaluation for this calibrator is based on its physical and chemical characteristics in comparison to a predicate device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Establishing ground truth by experts is not relevant for this type of calibrator submission. The "ground truth" for a calibrator relates to its assigned values and stability, which are typically determined through laboratory validation methods, not expert consensus on clinical cases.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is described.
-
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
- Not Applicable. This device is a calibrator, not an AI/ML-based diagnostic system for human readers.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device is a calibrator, not an algorithm or AI system.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Inferred. For a calibrator, the "ground truth" would be the assigned target values for the analytes at each level, established through highly accurate analytical methods traceable to primary reference materials (e.g., USP Digitoxin primary standard as mentioned). This is a metrological and analytical ground truth, not a clinical ground truth.
-
The sample size for the training set
- Not Applicable. This device is a calibrator, not an AI/ML system that requires a training set.
-
How the ground truth for the training set was established
- Not Applicable. No training set is involved.
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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. CraftDade Behring Inc.P.O. Box 6101Newark, 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 |
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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
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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
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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
§ 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.