(44 days)
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No
The document describes a calibrator for an in vitro diagnostic test, which is a chemical reagent product, not a software or imaging device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or data analysis techniques indicative of AI/ML.
No
The device is an in vitro diagnostic product used for the calibration of a progesterone method, not for treating a condition.
No
Explanation: This device is a calibrator, used to ensure the accuracy of a diagnostic method, but it does not directly diagnose a condition or disease.
No
The device is a liquid, frozen product containing biological components and is used for calibration of an in vitro diagnostic system, indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The LOCI 9 CAL is an in vitro diagnostic product for the calibration of the progesterone (PROG) 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 LOCI 9 CAL is an in vitro diagnostic product for the calibration of the progesterone (PROG) method on the Dimension Vista® System.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The LOCI 9 Calibrator is a liquid, frozen bovine serum albumin based product packaged as ten vials to a carton, with two vials at each of the 5 levels (A, B, C, D and E), 1.5 mL per vial. The LOCI 9 Calibrator includes progesterone, testosterone, buffers and preservatives.
Note: Although testosterone is present in this formulation, the LOCI 9 Calibrator will only be used with the Dimension Vista® Progesterone assay.
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)
The traceability, value assignment and stability of the Dimension Vista® LOCI 9 Calibrator have been validated following procedures of Siemens Healthcare Diagnostics, Inc.
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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510(k) Summary of Safety and Effectiveness for the Dimension Vista® LOCI 9 Calibrator (KC647)
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.
A. 510(k) Number: K113373
- B. Date of Preparation: October 28, 2011
C. Proprietary and Established Names:
Dimension Vista® LOCI 9 Calibrator, LOCI 9 CAL (KC647)
D. Applicant:
Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark, DE 19714-6101 Frances A. Dillon, Regulatory Affairs & Compliance Manager Office: (302) 631-6951 Fax: (302) 631-6299
E. Regulatory Information:
Dimension Vista® LOCI 9 Calibrator, LOCI 9 CAL (KC647)
-
- Regulation section: 21 CFR § 862.1150 Calibrator
-
- Classification: Class II
-
- Product Code: JIT Calibrator, Secondary
-
- Panel: Clinical Chemistry
F. Predicate Device:
The predicate device used to demonstrate substantial equivalence is the Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide Calibrator, PBNP CAL (KC676A), cleared under K080578.
G. Device Description:
The LOCI 9 Calibrator is a liquid, frozen bovine serum albumin based product packaged as ten vials to a carton, with two vials at each of the 5 levels (A, B, C, D and E), 1.5 mL per vial. The LOCI 9 Calibrator includes progesterone, testosterone, buffers and preservatives.
Note: Although testosterone is present in this formulation, the LOCI 9 Calibrator will only be used with the Dimension Vista® Progesterone assay.
H. Intended Use:
The LOCI 9 CAL is an in vitro diagnostic product for the calibration of the progesterone (PROG) method on the Dimension Vista® System.
I. Substantial Equivalence Information:
The Dimension Vista® LOCI 9 Calibrator, LOCI 9 CAL (KC4647) was compared to the predicate device, Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide Calibrator, PBNP CAL (KC676A), cleared under K080578. The following tables provide a comparison of the important similarities and differences between the devices:
1
Similarities
| Feature | New Device
Dimension Vista® LOCI 9
Calibrator, LOCI 9 CAL (KC647) | Predicate
Dimension Vista® N-terminal Pro-
Brain Natriuretic Peptide
Calibrator, PBNP CAL (KC676A) |
|--------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use. | For in vitro diagnostic use. |
| Matrix | Bovine serum albumin based | Bovine serum albumin based |
| Form | Liquid, frozen | Liquid, frozen |
| # Levels | Ten vials, two vials per level, 5 levels
(A, B, C, D and E) | Ten vials, two vials per level, 5
levels (A, B, C, D and E) |
Differences
| Feature | New Device
Dimension Vista® LOCI 9
Calibrator, LOCI 9 CAL (KC647) | Predicate
Dimension Vista® N-terminal Pro-
Brain Natriuretic Peptide
Calibrator, PBNP CAL (KC676A) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LOCI 9 CAL is an in vitro
diagnostic product for the calibration
of the progesterone (PROG) method
on the Dimension Vista® System. | The PBNP CAL is an in vitro
diagnostic product for the calibration
of the N-terminal Pro-Brain
Natriuretic Peptide (PBNP) method
on the Dimension Vista® System. |
| Analyte | Progesterone | Synthetic PBNP |
| Volume | 1.5 mL per vial | 1.0 mL per vial |
| Typical
Concentration
Levels | Five Levels, (0, 1.0, 8.0, 20.0 and
44.0 ng/mL) | Five levels, (0, 250, 1500, 12,000
and 36,750 pg/mL) |
J. Performance:
The traceability, value assignment and stability of the Dimension Vista® LOCI 9 Calibrator have been validated following procedures of Siemens Healthcare Diagnostics, Inc.
K. Conclusion:
The Dimension Vista® LOCI 9 Calibrator (KC4647) is substantially equivalent in design and intended use to the previously cleared Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide Calibrator (KC676A).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Healthcare Diagnostics, Inc. c/o Frances A. Dillon P.O. Box 6101 Mailstop 514 Newark, DE 19714-6101 USA
DEC 3 0 2011
Re: K113373
Trade Name: Dimension Vista® LOCI 9 Calibrator Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIT Dated: November 15, 2011 Received: November 16, 2011
Dear Ms. Dillon:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...
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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
N
Couriney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known):
Device Name:
Dimension Vista® LOCI 9 Calibrator
Indications for Use:
The LOCI 9 CAL is an in vitro diagnostic product for the calibration of the progesterone (PROG) method on the Dimension Vista® System.
X and/or Over-the-counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)
Heonath
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113373
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