(19 days)
The Dimension® AHDL Calibrator is an in vitro diagnostic product intended to be used to calibrate the Automated High Density Lipoprotein Cholesterol (AHDL) method for the Dimension® clinical chemistry system
The Dimension® AHDL Calibrator is a liquid bovine serum albumin based product. The Level 1 calibrator contains no detectable HDL Cholesterol. Levels 2 and 3 contain human HDL Cholesterol. The kit consists of six vials; two at each of three levels, containing 1 mL each.
The provided text is for a medical device called "Dimension® AHDL Calibrator," which is a calibrator for a clinical chemistry system. This type of device is used to ensure the accuracy of other diagnostic tests and is not a diagnostic device itself that makes clinical findings. As such, the typical "acceptance criteria" and "study" questions you've posed (like performance metrics, ground truth, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable in the way they would be for a diagnostic algorithm that interprets medical images or other patient data.
Instead, the submission focuses on substantial equivalence to a predicate device. This means the primary "acceptance criterion" is that the new device performs sufficiently similarly to a legally marketed device already on the market, such that it raises no new questions of safety or effectiveness.
Here's how the information provided relates to your questions, adapted for a calibrator device:
1. A table of acceptance criteria and the reported device performance:
For a calibrator, "performance" is assessed primarily by comparing its characteristics and intended use to a predicate device. The fundamental acceptance criterion for this 510(k) submission is that the Dimension® AHDL Calibrator is substantially equivalent to the Dimension® HDL Calibrator.
| Acceptance Criterion | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use | The AHDL Calibrator is intended to be used to calibrate the AHDL method for the Dimension® clinical chemistry system, which is similar to the predicate's use as a calibrator for high density lipoprotein cholesterol assays. |
| Analyte | The AHDL calibrator targets "Human high density lipoprotein Cholesterol," while the predicate targets "Cholesterol." (This distinction is noted but deemed acceptable for substantial equivalence). |
| Matrix | Both use a "bovine albumin" matrix for the AHDL calibrator and "Propanol" for the predicate. |
| Form | Both are "liquid." |
| Volume | AHDL Calibrator: 1.0 mL per vial. Predicate: 2.0 mL per vial. (Difference in volume is not considered a barrier to substantial equivalence). |
| Levels | Both have "3 levels." |
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 in the traditional sense. This is a calibrator, not a diagnostic algorithm that processes patient data. The "test set" for a calibrator would typically involve analytical performance studies internally (e.g., stability, homogeneity, value assignment), rather than a patient-data-driven test set for diagnostic accuracy. The provided document does not detail specific analytical performance studies, but rather focuses on comparing the device's characteristics to a predicate.
3. 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. Ground truth in the context of diagnostic algorithms (e.g., disease presence/absence) is not relevant for a calibrator. The "truth" for a calibrator is its assigned value, which is determined through metrologically sound methods, often traceable to reference materials, rather than expert consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used to resolve discrepancies in diagnoses or interpretations of patient data, which is not the function of a calibrator.
5. 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. An MRMC study is designed for diagnostic tools that involve human interpretation of medical cases, often with the assistance of AI. A calibrator does not involve human "readers" or "cases" in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device itself is a calibrator, not a diagnostic algorithm. Its function is to allow a diagnostic instrument (the Dimension® clinical chemistry system) to perform accurately when testing patient samples.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the provided document. If specific analytical performance studies were detailed (which they are not in this summary), the "ground truth" for a calibrator would typically involve its assigned values being traceable to higher-order reference materials, reference methods, or certified reference laboratories, thus ensuring accuracy and metrological traceability.
8. The sample size for the training set:
- Not applicable. Calibrators are developed and manufactured according to quality systems and analytical methods; they are not "trained" in the way an AI algorithm learns from labeled data.
9. How the ground truth for the training set was established:
- Not applicable. As calibrators are not "trained" with a training set of data like an AI model, the concept of establishing ground truth for a training set does not apply here.
In summary: The provided document is a 510(k) summary for a calibrator device. For such devices, the primary demonstration of safety and effectiveness lies in showing substantial equivalence to an already legally marketed predicate device, rather than through complex clinical performance studies with patient data and expert interpretations that would be typical for diagnostic algorithms. The information presented specifically supports the claim of substantial equivalence based on a comparison of device characteristics and intended use.
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NOV 1 8 1998
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: | Rebecca S. AyashDade Behring Inc.Building 500, Mailbox 514P.O. Box 6101Newark, DE 19714-6101 |
|---|---|
| Date of Preparation: | 10/29/98 |
| Device Name: | Dimension® AHDL Calibrator |
| Classification Name: | Calibrator, Secondary |
| Predicate Device: | Dimension® HDI Calibrator |
Device Description: The Dimension® AHDL Calibrator is a liquid bovine serum albumin based product. The Level 1 calibrator contains no detectable HDL Cholesterol. Levels 2 and 3 contain human HDL Cholesterol. The kit consists of six vials; two at each of three levels, containing 1 mL each.
Intended Use: The AHDL Calibrator is intended to be used to calibrate the AHDL method for the Dimension® clinical chemistry system.
Comparison to Predicate Device:
| Dimension® AHDL Calibrator | Dimension® HDL Calibrator | |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analyte | Human high density lipoproteinCholesterol | Cholesterol |
| Matrix | bovine albumin | Propanol |
| Form | Liquid | liquid |
| Volume | 1.0 mL per vial | 2.0 mL per vial |
| Levels | 3 levels | 3 levels |
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Comments on Substantial Equivalence: Both the Dimension® AHDL Calibrator for the system and the Dimension® HDL Calibrator are similar products. Both products are intended to be used as calibrators for high density lipoprotein cholesterol assays.
Conclusion: The Dimension® AHDL is substantially equivalent to the Dimension® HDL Calibrator based on the comparison summarized above.
Rebecca S. Ayers
Rebecca S. At Regulatory Affairs and Compliance Manager Date: 10/29/98
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NOV 1 8 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Rebecca S. Ayash Dade Behring, Inc. Building 500, Mailbox 514 P.O. Box 6101 Newark,Delaware 19714-6101
K983850 Re: Dimension® AHDL Calibrator Trade Name: Requlatory Class: II Product Code: JIT Dated: October 29, 1998 Received: October 30, 1998
Dear Ms. Ayash:
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 regulation (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 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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Paqe 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 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/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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Indications Statement
Device Name: Dimension® AHDL Calibrator
Indications for Use: The Dimension® AHDL Calibrator is an in vitro diagnostic product intended to be used to calibrate the Automated High Density Lipoprotein Cholesterol (AHDL) method for the Dimension® clinical chemistry system
Rebecca S. Ayash
Rebecca S. Ayasb Regulatory Affairs and Compliance Manager Date: 10/29/98
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Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number
Division Sign-Off Office of Device Evaluation
prescription use
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number k98 3880
§ 862.1150 Calibrator.
(a)
Identification. A 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. (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.