(77 days)
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No
The summary describes a chemical calibrator product for a clinical chemistry system, with no mention of AI or ML technology in its intended use, device description, or any other section.
No
The device is described as an "in vitro diagnostic product for the calibration of the LDI method," indicating it's used for lab testing, not for treating patients.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The ENZ I CAL is an in vitro diagnostic product for the calibration of the LDI method on the Dimension® clinical chemistry system."
No
The device is a liquid, bovine serum albumin based product containing lactate dehydrogenase, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ENZ I CAL is an in vitro diagnostic product for the calibration of the LDI method on the Dimension® clinical chemistry system."
This statement directly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The ENZ I CAL is an in vitro diagnostic product for the calibration of the LDI method on the Dimension® clinical chemistry system.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
ENZ I CAL is a liquid, bovine serum albumin based product containing lactate dehydrogenase (chicken heart). The calibrator packaging contains 4 vials, 2 vials of Level 2 and two vials of Level 3, with 1.5 mL per vial. Level 1 calibrator for LDI is not included in the ENZ I CAL carton. Purified Water Diluent (Cat. No. 710615901) or reagent grade water is required for use as Calibrator Level 1 for the LDI method.
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.
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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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510 (k) Summary for the Dimension® clinical chemistry system Enzyme I Calibrator (DC35)
| 510 (k) Number: | K081789 |
|---|---|
| Analyte: | Lactate dehydrogenase |
| Type of Test: | Calibrator Material |
| 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® clinical chemistry system Enzyme | Calibrator
Regulatory Information:
Regulation Section: 21 CFR § 862.1150 - Calibrator Classification: Class II
Product Code: JIT - Calibrator, Secondary
Panel: Clinical Chemistry
Intended Use:
The ENZ I CAL is an in vitro diagnostic product for the calibration of the LDI method on the Dimension® clinical chemistry system.
Device Description:
ENZ I CAL is a liquid, bovine serum albumin based product containing lactate dehydrogenase (chicken heart). The calibrator packaging contains 4 vials, 2 vials of Level 2 and two vials of Level 3, with 1.5 mL per vial. Level 1 calibrator for LDI is not included in the ENZ I CAL carton. Purified Water Diluent (Cat. No. 710615901) or reagent grade water is required for use as Calibrator Level 1 for the LDI method.
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Substantial Equivalence Information:
Comparison of the Dimension® clinical chemistry system Enzyme ! Calibrator, proposed device, to the predicate Roche Calibrator for automated systems.
| Item | New Device | Predicate Device |
|---|---|---|
| Analyte | Lactate dehydrogenase. | Multi-analyte; including lactate |
| dehydrogenase. | ||
| Use | For the calibration of the lactate | |
| dehydrogenase (LDI) method on the | ||
| Dimension® clinical chemistry system. | ||
| For in vitro diagnostic use. | For use in the calibration | |
| of quantitative Roche methods on Roche | ||
| clinical chemistry analyzers | ||
| as specified in the value sheet. | ||
| For in vitro diagnostic use. | ||
| Matrix | Liquid bovine serum albumin base with | |
| lactate dehydrogenase of chicken liver | ||
| origin. | Human serum base with lactate | |
| dehydrogenase of porcine heart origin. | ||
| Form | Liquid | Lyophilized |
| Traceability | IFCC LD at 37 ° C primary reference | |
| method. | Standardized against the original | |
| formulation and procedures recommended | ||
| by the IFCC. |
Comments on Substantial Equivalence:
Both the proposed ® clinical chemistry system Enzyme I Calibrator and the predicate Roche Calibrator for automated systems are traceable to IFCC reference method and used to calibrate IFCC traceable lactate dehydrogenase methods.
Conclusion:
The Dimension® Enzyme | Calibrator is substantially equivalent to the Roche Calibrator for automated systems based upon the information above.
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Image /page/2/Picture/1 description: The image contains the seal of the Department of Health & Human Services, USA. The seal features an eagle-like emblem with three stylized, curved lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics Inc. c/o Ms. Helen M. Lee 500 GBC Drive P.O. Box 6101, Mailbox 514 Newark, DE 19714-6101
SEP 1 0 2008
K081789 Rc:
Trade/Device Name: Dimension® Chemistry System Enzyme I Calibrator (ENZ I Cal) Regulation Number: 21 CFR§ 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: June 24, 2008 Received: June 25, 2008
Dear Ms. 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 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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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 toll-free number (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. Cooper, M.S., D.V.M.
Yéan 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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Indications for Use Statement
Kori759 510(k) Number (if known):
Device Name:
Dimension® clinical chemistry system Enzyme I Calibrator (ENZ I CAL)
Indications for Use:
The ENZ I CAL is an in vitro diagnostic product for the calibration of LDI method on the Dimension® clinical chemistry system.
Prescription Use (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benson
Division Sign-Off
vision Sign-Off
Office of In Vitro Diagnostic De lation and Safe