(84 days)
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No
The document describes a standard in vitro diagnostic calibrator product and does not mention any AI or ML components or functionalities.
No
The device is an in vitro diagnostic product used to calibrate a clinical chemistry method, not to treat a condition or disease.
No
The device is a calibrator for an in vitro diagnostic product, not a diagnostic device itself. It is used to calibrate the Lipase (LIPL) method, which then performs the diagnostic function.
No
The device description explicitly states it is a liquid bovine serum albumin-based product containing porcine pancreas lipase, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The LIPL Calibrator is an in vitro diagnostic product to be used to calibrate the Lipase (LIPL) method for the Dimension® clinical chemistry systems."
This statement directly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The LIPL Calibrator is an in vitro diagnostic product to be used to calibrate the Lipase (LIPL) method for the Dimension® clinical chemistry systems.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The LIPL calibrator is a liquid bovine serum albumin-based product. The level 1 calibrator contains no detectable lipase. Levels 2 and 3 contain porcine pancreas lipase. The kit consists of six vials, two vials of Calibrator Level 1, two vials of Calibrator Level 2, and two vials of Calibrator Level 3 which are ready for use (no preparation is required). The volume per vial is 1.0 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)
Traceability: The assigned values of the Dimension® LIPL Calibrator are traceable to Master Pool values, assigned on the Dimension® clinical chemistry system.
Master Pool level 1 of BSA base is assigned a value of 0 U/L. LIPL Master Pool bottle values levels 2 and 3 are assigned on multiple instruments calibrated with LIPL Anchor Pool. The LIPL Anchor Pool values are assigned using an external reference system (PBS/Precical®). A previous Master Pool lot is used as a control. Calibrators are prepared gravimetrically from porcine lipase. The concentration of each level is verified against Master Pool values.
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.
The document states "The Dimension® Clinical Chemistry System Lipase Calibrator (DC56) and the predicate device, the Dimension Vista® Enzyme 1 Calibrator were compared." without providing the K/DEN number for the predicate device.
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.
0
| 510(k) Summary for the | ||
|---|---|---|
| Dimension® Clinical Chemistry System Lipase Calibrator | ||
| (LIPL CAL - DC56) |
AUG - 4 2008
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.
May 8, 2008
| A. 510(k) Number: | 2081319 |
|---|---|
| B. Analyte: | Lipase |
| C. Type of Test: | Calibrator Material |
| D. Applicant: | Siemens Healthcare Diagnostics Inc, P.O. Box 6101, Newark, DE 19714-6101 |
| Victor M. Carrio, Regulatory Affairs and Compliance Manager | |
| Office: (302) 631-0376 Fax: (302) 631-6299 | |
| E. Proprietary and Established Names: | Dimension® Clinical Chemistry System Lipase Calibrator |
| (LIPL CAL - DC56) | |
| F. Regulatory Information: | |
| 1. Regulation section: | 21 CFR § 862-1150 - Calibrator |
| 2. Classification: | Class II |
| 3. Product Code: | JIT - Secondary Calibrator |
| 4. Panel: | Clinical Chemistry |
| G. Standard/Guidance Document Referenced: | |
| Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final,02/22/1999 | |
| ISO 14971:2007 Medical devices -Application of risk management to medical devices | |
| H. Intended Use: | The LIPL Calibrator is an in vitro diagnostic product to be used to calibrate the Lipase (LIPL) method for the Dimension® clinical chemistry systems. |
| I. Device Description: | The LIPL calibrator is a liquid bovine serum albumin-based product. The level 1 calibrator contains no detectable lipase. Levels 2 and 3 contain porcine pancreas lipase. The kit consists of six vials, two vials of Calibrator Level 1, two vials of Calibrator Level 2, |
.
i
1
1
and two vials of Calibrator Level 3 which are ready for use (no preparation is required). The volume per vial is 1.0 mL.
J. Substantial Equivalence Information:
The Dimension® Clinical Chemistry System Lipase Calibrator (DC56) and the predicate device, the Dimension Vista® Enzyme 1 Calibrator were compared. The following table provides a comparison of the important similarities and differences between the device and the predicate:
| Item | Device
Dimension® clinical
chemistry system Liquid
Lipase calibrator | Predicate Device
Dimension Vista® System
Enzyme 1 Calibrator |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LIPL Calibrator is an in
vitro diagnostic product to be
used to calibrate the Lipase
(LIPL) method for the
Dimension® clinical chemistry
systems. | The Vista® System Enzyme 1
Calibrator is an in vitro
diagnostic product for the
calibration of Amylase (AMY),
Gamma-Glutamyl Transferase
(GGT), Lactate Dehydrogenase
(LDH), Lipase (LIP), and
Pseudocholinesterase (PCHE)
methods on the Dimension
Vista® System. |
| Analytes | Lipase | Amylase, Gamma-Glutamyl
Transferase, Lactate
Dehydrogenase, Lipase, and
Pseudocholinesterase |
| Form | Liquid | Liquid |
| Traceability | Master Pool, Dimension®
clinical chemistry system
values. | Master Pool, Dimension® clinical
chemistry system values. |
| Matrix | Bovine serum base with Lipase
(porcine pancreas). | Bovine serum base with amylase
(human saliva), GGT (bovine
kidney), LDH (chicken heart),
lipase (porcine pancreas), and
PCHE (horse serum). |
| Number of
Levels | Three (3) levels. | Two (2) levels. |
K. Performance Characteristics:
Traceability: The assigned values of the Dimension® LIPL Calibrator are traceable to Master Pool values, assigned on the Dimension® clinical chemistry system.
Master Pool level 1 of BSA base is assigned a value of 0 U/L. LIPL Master Pool bottle values levels 2 and 3 are assigned on multiple instruments calibrated with LIPL Anchor Pool. The LIPL Anchor Pool values are assigned using an external reference system (PBS/Precical®). A previous Master Pool lot is used as a control. Calibrators are prepared gravimetrically from porcine lipase. The concentration of each level is verified against Master Pool
2
| values. | |||
|---|---|---|---|
| File Attachment | |||
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 4 2008
Siemens Healthcare Diagnostics Inc. c/o Mr. Victor M. Carrio Senior Manager of Regulatory Affairs P.O. Box 6101, Mailbox 514 Newark, DE 10714-6101
Re: K081319
Trade Name: Dimension® Lipase Calibrator (DC56) Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: July 11, 2008 Received: July 14, 2008
Dear Mr. Carrio:
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).
4
Page 2 -
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 (240) 276-0490. 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 tollofre and (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Coopes, M.S., D.v.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known): K081319
Device Name:
Dimension® Lipase Calibrator (DC56)
Indication For Use:
The LIPL Calibrator is an in vitro diagnostic product to be used to calibrate the Lipase (LIPL) method for the Dimension® clinical chemistry systems.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081319