(63 days)
The Dade Behring Dimension® ALDL Calibrator is an in vitro diagnostic product intended to be used to calibrate low density lipoprotein cholesterol on Dade Behring Dimension® clinical chemistry systems.
The Dade Behring Dimension® ALDL Calibrator is an in vitro diagnostic device intended for use on Dade Behring Dimension® clinical chemistry systems for medical purposes to establish points of reference that are used in determination of low density lipoprotein cholesterol in human serum and plasma
The Dade Behring Dimension® ALDL Calibrator is a 3 level, lyophilized product. The carton consists of six vials; two at each of three levels. Lot specific Value Assignment is made according to the process outlined in ATTACHMENT C. The Stability Testing Protocol established for determining long-term, real-time stability is provided in ATTACHMENT D. Shelf-life stability (Expiration Dating) dating reflects the real-time stability data available at commercialization and is on file at Dade Behring.
The provided text is a 510(k) summary for the Dade Behring Dimension® ALDL Calibrator. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance criteria or a standalone study as would be expected for a novel diagnostic device's clinical performance.
Therefore, many of the requested details regarding acceptance criteria, study sizes, expert qualifications, and ground truth establishment cannot be fully extracted from this document as presented. This document is a regulatory submission for a calibrator, which establishes reference points for a diagnostic test, not the diagnostic test itself. The performance of the calibrator is more about its stability, value assignment, and consistent behavior within the system, rather than diagnostic accuracy against a ground truth.
However, I can provide information based on what is available and explain why other information is missing.
Acceptance Criteria and Study for Dade Behring Dimension® ALDL Calibrator
As this document is a 510(k) premarket notification for a calibrator, the "acceptance criteria" and "device performance" are framed in terms of its ability to properly calibrate the associated clinical chemistry system, not in terms of diagnostic accuracy on patient samples. The study described is a comparison to a predicate calibrator to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion | Acceptance (Implied for Substantial Equivalence to Predicate Calibrator) | Reported Device Performance (Dade Behring Dimension® ALDL Calibrator) |
|---|---|---|
| Intended Use | Calibrate human cholesterol on Dimension® systems (LDL vs HDL) | Calibrate human low density lipoprotein cholesterol on Dimension® systems |
| Levels | 3 levels; two vials/level | 3 levels; two vials/level |
| Form | Lyophilized (predicate was liquid, but form difference noted) | Lyophilized |
| Matrix | Bovine serum albumin with added human LDL (predicate had HDL) | Bovine serum albumin with added human LDL |
| Value Assignment Process | Documented and established (see ATTACHMENT C) | Performed according to outlined process (ATTACHMENT C) |
| Shelf-life Stability | Established through testing (see ATTACHMENT D) | Reflects real-time stability data available at commercialization (on file) |
Note: The acceptance criteria here are implicitly met by demonstrating similarity in design and function to the predicate device, specifically another calibrator (AHDL Calibrator). The document does not provide quantitative performance metrics for calibration accuracy or precision, but rather states that the value assignment and stability testing processes were followed and data is on file.
2. Sample Size Used for the Test Set and Data Provenance
This document describes a regulatory submission for a calibrator, not a diagnostic device that analyzes patient samples as a "test set." Therefore, the concept of a "test set" from patient data with ground truth does not directly apply in the way it would for a diagnostic algorithm.
- Sample Size (for Calibrator Development/Validation): Not explicitly stated in terms of patient samples. The document refers to "Lot specific Value Assignment" and "Stability Testing Protocol," implying internal testing on calibrator lots and stability samples.
- Data Provenance: Not applicable in the context of patient data. The development and testing would have been conducted by Dade Behring Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As this is a calibrator, "ground truth" refers to the assigned values of the calibrator levels, which are likely established through a highly controlled, traceable process, possibly involving reference methods and metrology, rather than expert interpretation of patient samples. Experts would be involved in the analytical and manufacturing processes, not in establishing a "ground truth" for a diagnostic outcome.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" of patient data requiring expert adjudication mentioned in this document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The device in question is a laboratory calibrator.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical calibrator product for a clinical chemistry system, not an algorithm. Its "performance" relates to its chemical and physical properties and its ability to establish reference points for an automated instrument.
7. The Type of Ground Truth Used
The "ground truth" for a calibrator refers to the assigned concentration values for each level of the calibrator. This is established through a rigorous "Value Assignment" process (referenced as ATTACHMENT C), which would typically involve:
- Reference measurement procedures.
- Traceability to higher-order international standards if available.
- Internal validation and quality control procedures.
It is not expert consensus on patient samples, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML algorithm that requires a training set.
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MAY 0 8 2002
Summary of Safety and Effectiveness Information
Dade Behring Dimension® ALDL Calibrator
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. VaughtDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101 |
|---|---|
| Date of Preparation: | March 5, 2002 |
| Name of Product: | Dade Behring Dimension® ALDL Calibrator |
| FDA Classification Name: | Calibrator, Secondary; Class II ; 75JIT |
| Predicate Device: | The Dade Behring Dimension® AHDL Calibrator (K983850) |
| Device Description: | The Dade Behring Dimension® ALDL Calibrator is a 3 level,lyophilized product. The carton consists of six vials; two ateach of three levels.Lot specific Value Assignment is made according to the processoutlined in ATTACHMENT C.The Stability Testing Protocol established for determining long-term, real-time stability is provided in ATTACHMENT D.Shelf-life stability (Expiration Dating) dating reflects the real-time stability data available at commercialization and is on fileat Dade Behring. |
| Intended Use: | The Dade Behring Dimension® ALDL Calibrator is an in vitrodiagnostic product intended to be used to calibrate low density |
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lipoprotein cholesterol on Dade Behring Dimension® clinical chemistry systems.
Comparison to Predicate Device:
| Feature | Dimension® ALDL Calibrator | Dimension® AHDL Calibrator |
|---|---|---|
| Intended Use: | In vitro use.For calibration of humanlow density lipoproteincholesterol on Dimension®systems | In vitro use.For calibration of humanhigh density lipoproteincholesterol on Dimension®systems |
| Levels: | 3 levels; two vials/level | 3 levels; two vials/level |
| Form: | Lyophilized | Liquid |
| Matrix: | bovine serum albuminwith added human LDL | bovine serum albuminwith added human HDL |
Comments on Substantial Equivalence:
The proposed Dade Behring Dimension® ALDL Calibrator and the predicate Dade Behring AHDL Calibrator are similar in vitro diagnostic products. Both are intended be used as cholesterol calibrators for the Dade Behring Dimension® clinical chemistry system analyzer family.
Conclusion:
The Dade Behring Dimension® ALDL Calibrator is substantially equivalent to other lipoprotein calibrators such as the Dade Behring Dimension® AHDL Calibrator based on its design and function as summarized above.
Rampart
Richard M. Vaught Regulatory Affairs and Compliance Manager March 5, 2002
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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping silhouettes suggesting a sense of community or interconnectedness.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring Inc. Chemistry/Immunochemistry Glasgow Business Community Bldg. 500, M. S. 514 P.O. Box 6101 Newark, DE 19714-6101
MAY 0 8 2002
Re: K020723
Trade/Device Name: Dade Behring Dimension® ALDL Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator, secondary Regulatory Class: Class II Product Code: JIT Dated: March 5, 2002 Received: March 6, 2002
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 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 FOR USE STATEMENT
Device Name:
Dade Behring Dimension® ALDL Calibrator
Indications for Use:
The Dade Behring Dimension® ALDL Calibrator is an in vitro diagnostic device intended for use on Dade Behring Dimension® clinical chemistry systems for medical purposes to establish points of reference that are used in determination of low density lipoprotein cholesterol in human serum and plasma
Rmm Vainright
Richard M. Vaught Regulatory Affairs and Compliance Manager
March 5, 2002
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Scan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020723
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-counter Use_
(Optional format 1-2-96)
000004
§ 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.