(84 days)
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 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.
The provided text describes a 510(k) premarket notification for a medical device, specifically the Dimension® Clinical Chemistry System Lipase Calibrator (LIPL CAL - DC56). This device is a calibrator material used to calibrate the Lipase (LIPL) method for Dimension® clinical chemistry systems.
It is important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive performance studies with acceptance criteria in the same way one might assess the accuracy of a diagnostic test. For a calibrator, the primary performance characteristic is its traceability to reference materials and the consistency of its assigned values.
Here's an analysis of the provided information concerning acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
For calibrators, explicit "acceptance criteria" in terms of clinical sensitivity/specificity or other diagnostic performance metrics are not typically provided. Instead, the focus is on traceability and value assignment consistency.
| Acceptance Criteria (Implied for a Calibrator) | Reported Device Performance |
|---|---|
| Traceability to Master Pool Values | The assigned values of the Dimension® LIPL Calibrator are traceable to Master Pool values, assigned on the Dimension® clinical chemistry system. |
| Consistent Value Assignment of Master Pool Level 1 | Master Pool level 1 of BSA base is assigned a value of 0 U/L. |
| Consistent Value Assignment of Master Pool Levels 2 & 3 | LIPL Master Pool bottle values levels 2 and 3 are assigned on multiple instruments calibrated with LIPL Anchor Pool. |
| Traceability of Anchor Pool | The LIPL Anchor Pool values are assigned using an external reference system (PBS/Precical®). |
| Control Against Previous Lots | A previous Master Pool lot is used as a control. |
| Verification of Calibrator Concentration | Calibrators are prepared gravimetrically from porcine lipase. The concentration of each level is verified against Master Pool values. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly define a "test set" in the traditional sense for evaluating diagnostic performance. The evaluation described relates to the traceability and value assignment process of the calibrator.
- Sample Size: The master pool levels 2 and 3 are assigned on "multiple instruments." The number of instruments is not specified. Calibrator concentrations are verified against Master Pool values, which implies testing a certain number of calibrator vials, but the exact number isn't given.
- Data Provenance: The data comes from internal testing and validation by Siemens Healthcare Diagnostics Inc. No country of origin for patients or samples is relevant as this is a calibrator, not a patient-facing diagnostic. The studies are by nature prospective in the sense of manufacturing and validating new lots of calibrator.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable in the context of this calibrator validation. The "ground truth" for calibrators is established through a hierarchical traceability chain to reference materials and methods, not expert consensus on patient data.
- Qualifications of Experts: Not applicable. The process relies on laboratory procedures, validated analytical methods, and qualified personnel following good manufacturing and laboratory practices, rather than expert interpretation of a test set.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" of patient samples requiring expert adjudication. The process involves analytical measurements and comparison to established reference values and internal controls.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a calibrator, not a diagnostic device that requires human interpretation. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The performance described is inherent to the calibrator material and its assigned values, which are determined through analytical procedures, not human-in-the-loop interpretation. The "algorithm" here is the analytical method used to assign the calibrator values and the instrument's subsequent calibration function.
7. The Type of Ground Truth Used
The "ground truth" for the calibrator is established through:
- Reference Materials/Methods: The LIPL Anchor Pool values are assigned using an external reference system (PBS/Precical®).
- Gravimetric Preparation: Calibrators are prepared gravimetrically from porcine lipase, providing a known starting concentration.
- Hierarchical Traceability: The process involves tracing values from a Master Pool, which is itself traceable to an Anchor Pool, and ultimately to an external reference system.
8. The Sample Size for the Training Set
Not applicable. As a calibrator, this device does not involve machine learning or AI that would require a "training set." Its values are determined through analytical and manufacturing processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is involved.
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| 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, |
.
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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 | DeviceDimension® clinicalchemistry system LiquidLipase calibrator | Predicate DeviceDimension Vista® SystemEnzyme 1 Calibrator |
|---|---|---|
| Intended Use | The LIPL Calibrator is an invitro diagnostic product to beused to calibrate the Lipase(LIPL) method for theDimension® clinical chemistrysystems. | The Vista® System Enzyme 1Calibrator is an in vitrodiagnostic product for thecalibration of Amylase (AMY),Gamma-Glutamyl Transferase(GGT), Lactate Dehydrogenase(LDH), Lipase (LIP), andPseudocholinesterase (PCHE)methods on the DimensionVista® System. |
| Analytes | Lipase | Amylase, Gamma-GlutamylTransferase, LactateDehydrogenase, Lipase, andPseudocholinesterase |
| Form | Liquid | Liquid |
| Traceability | Master Pool, Dimension®clinical chemistry systemvalues. | Master Pool, Dimension® clinicalchemistry system values. |
| Matrix | Bovine serum base with Lipase(porcine pancreas). | Bovine serum base with amylase(human saliva), GGT (bovinekidney), LDH (chicken heart),lipase (porcine pancreas), andPCHE (horse serum). |
| Number ofLevels | 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
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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).
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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
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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
§ 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.