(95 days)
Not Found
No
The summary describes a calibrator for an in vitro diagnostic test, which is a chemical reagent used for calibration, not a device that processes data or images using AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The product is described as an "in vitro diagnostic product for the calibration of the lactate dehydrogenase (LDI) method". It is used for in vitro diagnostic purposes, not for treating patients.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "The Enzyme 5 Calibrator (ENZ 5 CAL) is an in vitro diagnostic product".
No
The device is an in vitro diagnostic product described as a liquid, bovine serum albumin based product containing lactate dehydrogenase, packaged in vials. This description clearly indicates a physical, chemical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Enzyme 5 Calibrator (ENZ 5 CAL) is an in vitro diagnostic product for the calibration of the lactate dehydrogenase (LDI) method on the Dimension Vista® System."
This statement directly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The Enzyme 5 Calibrator (ENZ 5 CAL) is an in vitro diagnostic product for the calibration of the lactate dehydrogenase (LDI) method on the Dimension Vista® System.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
ENZ 5 CAL is a liquid, bovine serum albumin based product containing lactate dehydrogenase (chicken heart). The calibrator, one level (Calibrator A), comes packaged with three vials at 1.5 mL per vial. System water, the zero level calibrator does not come packaged with the calibrator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
Stability:
-
Shelf-life
Target shelf life for the Dimension Vista® ENZ 5 CAL is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 2-8℃ with control stored at -20°C and -70°C. The method is calibrated each month with the -70°C control material. The 2-8°C and -20°C materials are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined. Shelf life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Siemens Healthcare Diagnostics Inc. -
Open Vial
Vials are opened on day zero. A quantity sufficient for multiple calibrations is removed; the vials are recapped and stored at 2-8°C. Opened vials are tested on days 0, 15 and 32; freshly opened vials are also tested on days 15 and 32. An open vial, not on board the instrument, but recapped and stored at 2-8°C is stable for 30 days. -
Punctured Vial
Vials are punctured on day zero with the appropriate quantity removed, leaving sufficient volume for one calibration and dead volume. Punctured vials are recapped and stored at 2-8°. Four recapped vials are tested on day zero. Two recapped vials and eight punctured vials are tested on approximately days 3, 8 and 15. Two freshly opened vials are tested at each test point.
A vial punctured by the instrument and stored on board is stable for seven days.
-
-
Traceability: The assigned values for the Dimension Vista® ENZ 5 CAL are assigned from Master pools that are traceable to the IFCC Reference Measurement Procedure.
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Value Assignment:
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Anchor Pool
Two levels of LD Anchor pools (Levels 2 and 3) are prepared using pooled human serum samples with normal and elevated LD values; the final target concentrations of Level 2=625 U/L and Level 3=1250 U/L. Values are assigned to the Anchor Pools by the IFCC LD Reference Measurement Procedure by a Reference Laboratory approved by the Joint Committee for Traceability in Laboratory Medicine (JCTLM). Level 1(system water) is assigned a value of zero U/L.
The reference laboratory uses the IFCC LD Reference Measurement Procedure to assign values to the Anchor Pools against calibrators with Reference Measurement Procedure values. The calibrators are prepared by the Reference Laboratory using pooled human sera with Reference Measurement Procedure values for the catalytic concentration of the LD enzyme. They are used for calibration of the Reference Laboratory measurements. The performance and the long term stability of the calibrators have been confirmed by the Reference Laboratory.
The Control used during the assignment of Anchor Pools at the Reference Laboratory is also produced and certified by the Reference Laboratory and is used to ascertain the accuracy of the test runs performed to assign values to the Siemens Anchor Pools. -
Masterpool
Two levels of LD Masterpools (Levels 2 and 3) are produced by adding the appropriate volume of LD stock with a known concentration into an aqueous Bovine Serum Albumin matrix. Level 1 of the LD Masterpool, system water, is assigned zero U/L. Levels 2 and 3 of the LD Masterpool are assigned from Anchor Pool calibration curves, using three instruments and three lactate dehydrogenase (LDI) reagent lots. Each instrument is calibrated three times with Anchor Pools for a total of 9 curves. Values for five replicates each of Level 2 and Level 3 of the Masterpool are determined from each Anchor Pool curve, resulting in 45 replicates each for LD Masterpool Level 3. A commercial quality control material, Bio-rad Multiqual QC, assayed for the IFCC LD method, is used as a control in the assignment of the Masterpools. The LD Anchorpools and Masterpools are stored at -70°C. -
Commercial Calibrator
For commercial calibrators, a stock solution is made by adding LD powder gravimetrically to the stock solution at the target concentration. The commercial calibrator is made by adding calculated quantities of stock solution to the calibrator base at the appropriate concentration for Calibrator A. Before vial filling, the concentration of the calibrator is verified by measuring LD recovery on an instrument calibrated with LD Masterpools.
For value assignment of the commercial calibrators Siemens uses a three point LD Masterpool Linear curve. After filling, the final bottle values are assigned to Calibrator A, using LD Masterpools. The final bottle values of the commercial lots are assigned against the LD Masterpools using three instruments and three LDI reagent lots. Each instrument is calibrated three times with LD Masterpools for a total of 9 standard curves. Five replicates of the commercial lot Calibrator A are tested with each Masterpool curve yielding 45 replicates. The assigned Calibrator A value is the mean of the 45 replicates. A previously assigned commercial lot is used as the control for the assignment of new commercial lots.
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Dimension® clinical chemistry system Enzyme I Calibrator. (K083462 refers to the current device, not a predicate)
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.
Not Found
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).
Not Found
§ 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
FEB. 2 7 2009
510 (k) Summary for the Dimension Vista® System Enzyme 5 Calibrator (KC350)
510 (k) Number: Lactate dehydrogenase Analyte: Calibrator Material Type of Test: Applicant: Siemens Healthcare Diagnostics Inc P.O. Box 6101 Newark, DE 19714-6101 Helen M. Lee Regulatory Affairs and Compliance Manager Office Phone: 302.631.8706 Fax: 302.631.6299 Proprietary and Established Name: Dimension Vista® System Enzyme 5 Calibrator Requlatory Information: Requlation Section: 21 CFR § 862.1150 - Calibrator Classification: Class II Product Code: JIT - Calibrator, Secondary
Panel: Clinical Chemistry
Intended Use:
The Enzyme 5 Calibrator (ENZ 5 CAL) is an in vitro diagnostic product for the calibration of the lactate dehydrogenase (LDI) method on the Dimension Vista® System.
Device Description:
ENZ 5 CAL is a liquid, bovine serum albumin based product containing lactate dehydrogenase (chicken heart). The calibrator, one level (Calibrator A), comes packaged with three vials at 1.5 mL per vial. System water, the zero level calibrator does not come packaged with the calibrator.
1
Substantial Equivalence Information:
Comparison of the Dimension Vista® System Enzyme 5 Compansen of the Bithoice) to the predicate Dimension® clinical chemistry system Enzyme I Calibrator.
| Item | New Device | Predicate Device |
|---|---|---|
| Analyte | Lactate dehydrogenase. | Lactate dehydrogenase. |
| Intended Use | For the calibration of the lactate | |
| dehydrogenase (LDI) method on the | ||
| Dimension Vista® System. | ||
| For in vitro diagnostic use. | For the calibration of the lactate | |
| dehydrogenase (LDI) method on the | ||
| Dimension® clinical chemistry system. | ||
| For in vitro diagnostic use. | ||
| Matrix | Liquid bovine serum albumin base | |
| with lactate dehydrogenase of | ||
| chicken liver origin. | Liquid bovine serum albumin base with | |
| lactate dehydrogenase of chicken liver | ||
| origin. | ||
| Form | Liquid | Liquid |
| Traceability | IFCC LD at 37° C primary reference | |
| method. | IFCC LD at 37° C primary reference | |
| method |
Similarities
Differences
| Item | New Device | Predicate Device |
|---|---|---|
| Calibrator | ||
| Packaging | One Level – Calibrator A | Two Levels – Level 2 and Level 3 |
| Calibration | ||
| Levels | Two Levels: | |
| · System water is Level 1 |
· Calibrator A is Level 2 | Three Levels:
· Purified Water Diluent or reagent
grade water is Level 1
· Level 2 Calibrator
· Level 3 Calibrator |
2
Standard/Guidance Documents Referenced:
-
- Guidance: Guidance for Industry Abbreviated 510 (k) Submissions for In Vitro Diagnostic Calibrators; February 22, 1999
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- Standards: CEN 13640 Stability testing of In-Vitro Diagnostic Devices ISO 14971:2000 Medical devices - Application of risk management to medical devices
Performance Characteristics:
-
- Stability:
- Shelf-life
Target shelf life for the Dimension Vista® ENZ 5 CAL is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 2-8℃ with control stored at -20°C and -70°C. The method is calibrated each month with the -70°C control material. The 2-8°C and -20°C materials are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined. Shelf life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Siemens Healthcare Diagnostics Inc.
Open Vial
Vials are opened on day zero. A quantity sufficient for multiple calibrations is removed; the vials are recapped and stored at 2-8°C. Opened vials are tested on days 0, 15 and 32; freshly opened vials are also tested on days 15 and 32. An open vial, not on board the instrument, but recapped and stored at 2-8°C is stable for 30 days.
Punctured Vial
Vials are punctured on day zero with the appropriate quantity removed, leaving sufficient volume for one calibration and dead volume. Punctured vials are recapped and stored at 2-8°. Four recapped vials are tested on day zero. Two recapped vials and eight punctured vials are tested on approximately days 3, 8 and 15. Two freshly opened vials are tested at each test point.
A vial punctured by the instrument and stored on board is stable for seven days.
- Traceability: The assigned values for the Dimension Vista® ENZ 5 CAL are assigned from Master pools that are traceable to the IFCC Reference Measurement Procedure.
3
Value Assignment:
Anchor Pool
Two levels of LD Anchor pools (Levels 2 and 3) are prepared using pooled human serum samples with normal and elevated LD values; the final target concentrations of Level 2=625 U/L and Level 3=1250 U/L. Values are assigned to the Anchor Pools by the IFCC LD Reference Measurement Procedure by a Reference Laboratory approved by the Joint Committee for Traceability in Laboratory Medicine (JCTLM). Level 1(system water) is assigned a value of zero U/L.
The reference laboratory uses the IFCC LD Reference Measurement Procedure to assign values to the Anchor Pools against calibrators with Reference Measurement Procedure values. The calibrators are prepared by the Reference Laboratory using pooled human sera with Reference Measurement Procedure values for the catalytic concentration of the LD enzyme. They are used for calibration of the Reference Laboratory measurements. The performance and the long term stability of the calibrators have been confirmed by the Reference Laboratory.
The Control used during the assignment of Anchor Pools at the Reference Laboratory is also produced and certified by the Reference Laboratory and is used to ascertain the accuracy of the test runs performed to assign values to the Siemens Anchor Pools.
Masterpool
Two levels of LD Masterpools (Levels 2 and 3) are produced by adding the appropriate volume of LD stock with a known concentration into an aqueous Bovine Serum Albumin matrix. Level 1 of the LD Masterpool, system water, is assigned zero U/L. Levels 2 and 3 of the LD Masterpool are assigned from Anchor Pool calibration curves, using three instruments and three lactate dehydrogenase (LDI) reagent lots. Each instrument is calibrated three times with Anchor Pools for a total of 9 curves. Values for five replicates each of Level 2 and Level 3 of the Masterpool are determined from each Anchor Pool curve, resulting in 45 replicates each for LD Masterpool Level 3. A commercial quality control material, Bio-rad Multiqual QC, assayed for the IFCC LD method, is used as a control in the assignment of the Masterpools. The LD Anchorpools and Masterpools are stored at -70°C.
4
3. Value Assignment (cont):
Commercial Calibrator
For commercial calibrators, a stock solution is made by adding LD powder gravimetrically to the stock solution at the target concentration. The commercial calibrator is made by adding calculated quantities of stock solution to the calibrator base at the appropriate concentration for Calibrator A. Before vial filling, the concentration of the calibrator is Masterpools. verified by measuring LD recovery on an instrument calibrated with LD
For value assignment of the commercial calibrators Siemens uses a three point LD Masterpool Linear curve. After filling, the final bottle values are assigned to Calibrator A, using LD Masterpools. The final bottle values of the commercial lots are assigned against the LD Masterpools using three instruments and three LDI reagent lots. Each instrument is calibrated three times with LD Masterpools for a total of 9 standard curves. Five replicates of the commercial lot Calibrator A are tested with each Masterpool curve yielding 45 replicates. The assigned Calibrator A value is the mean of the 45 replicates. A previously assigned commercial lot is used as the control for the assignment of new commercial lots.
Comments on Substantial Equivalence:
Both the proposed Dimension Vista® Enzyme 5 Calibrator and the predicate Dimension® Enzyme I Calibrator are traceable to IFCC reference method and are used to calibrate IFCC traceable lactate dehydrogenase methods.
Conclusion:
The Dimension Vista® Enzyme 5 Calibrator is substantially equivalent to Dimension® Enzyme I Calibrator based upon the information above.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics c/o Helen M. Lee Regulatory Affairs and Compliance Manager 500 GBC Drive M/S 514 Newark, DE 19714-6101
FEB 27 2005
Re: K083462
Trade/Device Name: Dimension Vista® System Enzyme 5 Calibrator (ENZ 5 CAL) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: November 21, 2008 Received: December 15, 2008
Dear Helen M. Lee:
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 iudications for use stated in the enclosure) to legally marketed predicate devices marketed in intelligence 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, Drig 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 registments of insting 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 devive can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In additions FDA may publish further announcements concerning your device in the Federal Parater.
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 COMP 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 220).
6
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 (301) 594-3084. 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 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,
Coty C. He
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
7
Indication for Use
: 510(k) Number (if known): K083462
Device Name: Dimension Vista® System Enzyme 5 Calibrator (ENZ 5 CAL)
Indication For Use: The ENZ 5 CAL is an in vitro diagnostic product for the calibration of the lactate dehydrogenase (LDI) method on the Dimension Vista® System.
Prescription Use _ ਮ (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)
Ruthecharlen
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083462