(63 days)
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No
The document describes a calibrator for a clinical chemistry system, which is a standard laboratory reagent, and contains no mention of AI or ML technology.
No
This device is an in vitro diagnostic product intended to calibrate clinical chemistry systems for determining low-density lipoprotein cholesterol, not for therapeutic use on a patient.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "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." It also identifies it as an "in vitro diagnostic device."
No
The device description explicitly states it is a "lyophilized product" consisting of "six vials," indicating it is a physical, chemical calibrator, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "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..."
This clearly identifies the device as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
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.
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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§ 862.1150 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.
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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. Vaught
Dade Behring Inc.
P.O. Box 6101
Newark, 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 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. |
| Intended Use: | The Dade Behring Dimension® ALDL Calibrator is an in vitro
diagnostic 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 human | ||
| low density lipoprotein | ||
| cholesterol on Dimension® | ||
| systems | In vitro use. | |
| For calibration of human | ||
| high density lipoprotein | ||
| cholesterol on Dimension® | ||
| systems | ||
| Levels: | 3 levels; two vials/level | 3 levels; two vials/level |
| Form: | Lyophilized | Liquid |
| Matrix: | bovine serum albumin | |
| with added human LDL | bovine serum albumin | |
| with 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