(44 days)
LOCI 8 CAL is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL) and estradiol (E2)methods on the Dimension Vista® Systems .
LOCI 8 CAL is a multi-analyte, liquid, frozen bovine serum albumin based product containing hormone, recombinant human prolactin, estradiol, buffers and preservatives.
The provided K101460 510(k) summary for the LOCI 8 Calibrator is for an in vitro diagnostic product (calibrator). The information requested regarding acceptance criteria and study details (like sample size for test sets, ground truth establishment, MRMC studies, standalone performance) is typically associated with studies evaluating the diagnostic performance of a medical device against a ground truth, often for imaging or patient-facing diagnostic tests.
A calibrator like the LOCI 8 CAL is not assessed in the same way as a diagnostic device. Its performance is primarily evaluated based on its ability to accurately calibrate an assay, ensuring the assay provides correct quantitative results for specific analytes (FSH, LH, Prolactin, Estradiol). The "acceptance criteria" for a calibrator would revolve around its manufacturing specifications, stability, and its impact on the accuracy and precision of the assays it calibrates.
Therefore, many of the requested categories are not applicable in the context of this 510(k) summary for a calibrator. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving diagnostic accuracy.
Here's a breakdown of the available information and why some categories are not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" and "reported device performance" in the typical sense of a diagnostic test's sensitivity, specificity, or accuracy. Instead, it describes the features and characteristics of the calibrator and compares them to predicate devices to demonstrate substantial equivalence.
| Feature | Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (Characteristics) |
|---|---|---|
| Intended Use | Must be for in vitro diagnostic calibration of FSH, LH, Prolactin, and Estradiol methods on the Dimension Vista® system, similar to predicate devices. | LOCI 8 CAL is an in vitro diagnostic product for the calibration of the follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL) and estradiol (E2) methods on the Dimension Vista® system. |
| Constituents | Must contain FSH, LH, Prolactin, and Estradiol. | LOCI 8 CAL is a multi-analyte, liquid, frozen bovine serum albumin based product containing FSH, LH, human chorionic gonadotropin hormone, recombinant human prolactin, estradiol, buffers and preservatives. (Note: "human chorionic gonadotropin hormone" is mentioned in the description, but not in the intended use or similarity tables for predicates, suggesting a slight discrepancy or broader base, but the key analytes are consistent). |
| Traceability of Constituents - FSH | Traceable to an internationally recognized standard. | FSH - WHO 1st IS for FSH 92/510 |
| Traceability of Constituents - LH | Traceable to an internationally recognized standard. | LH - WHO 2nd IS for LH 80/552 |
| Traceability of Constituents - Prolactin | Traceable to an internationally recognized standard. | Prolactin - WHO 3rd IS for PRL 84/500 |
| Traceability of Constituents - Estradiol | Traceable to an internationally recognized reference measurement procedure. | Estradiol - Isotope Dilution gas chromatography mass spectroscopy reference measurement procedure (ID-GC/MS). |
| Form | Must be suitable for its intended use as a calibrator, though liquid vs. lyophilized is acknowledged as a difference. | frozen liquid, bovine serum albumin. |
| Levels | Must provide appropriate calibration points. (Implied that 5 levels are sufficient). | 5 levels. |
| Stability and Storage | Must demonstrate adequate stability for its shelf life and in-use period. | Stored at -25 to -15 °C. Stable, thawed and unopened for 8 days @ 2 – 8 °C. (The document mentions "Calibratituted for 28 days @ 2 - 8 ° C" in the predicate description, which seems to imply a difference in post-reconstitution/thaw stability, but details specific to LOCI 8 CAL are "8 days @ 2-8 °C"). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable. This 510(k) summary is for a calibrator. There is no "test set" of patient samples in the context of diagnostic performance evaluation. The data would pertain to internal validation studies of the calibrator manufacturing and its performance with the associated assay, not diagnostic accuracy on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not Applicable. Ground truth, in the sense of a clinical diagnosis, is not established for a calibrator. The "truth" for a calibrator is its assigned value, established through a rigorous process of traceability to international standards and reference methods (e.g., WHO standards for hormones, ID-GC/MS for Estradiol), performed by analytical chemists or metrology experts within the manufacturer's R&D.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. Adjudication methods are used to resolve discrepancies in expert interpretations of diagnostic data, which is not relevant for a calibrator.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. MRMC studies are for evaluating observer performance, particularly relevant for imaging devices or other diagnostic tests requiring human interpretation. This is a calibrator, with no human interpretation component in its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a calibrator, not an algorithm. Its "performance" is its ability to provide accurate and stable calibration points for an automated assay.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As explained in point 3, the "ground truth" for a calibrator is its assigned value based on traceability to international reference standards and/or reference measurement procedures.
- FSH: WHO 1st IS for FSH 92/510
- LH: WHO 2nd IS for LH 80/552
- Prolactin: WHO 3rd IS for PRL 84/500
- Estradiol: Isotope Dilution gas chromatography mass spectroscopy (ID-GC/MS) reference measurement procedure.
8. The sample size for the training set
Not Applicable. This is a calibrator, not a machine learning model that requires a training set. The term "training set" is not relevant here.
9. How the ground truth for the training set was established
Not Applicable. See reasons for point 8.
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510(k) Summary for LOCI 8 Calibrator
This summary of 510(k) safety and effectiveness information is being submitted in accordance This summaly of 510(K) Salety and Shouw 21.0.1.
with the requirements of SMDA 1990 and 21 CFR 807.92.
Siemens Healthcare Diagnostics, Inc.
The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________
| 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation: |
|---|
| -------------------------------------------------------------------------------------- |
| Manufacturer: | |
|---|---|
| --------------- | -- |
500 GBC Drive
JUL - 9 2010
Newark, DE 19714
Siemens Healthcare Diagnostics, Inc. Contact Information:
500 GBC Drive
Newark, DE 19714
Attn: A. Kathleen Ennis
Tel: 302-631-9352
Fax: 302-631-6299
April 26, 2010 Preparation date:
LOCI 8 Calibrator 2. Device Name:
| Classification: | Class II |
|---|---|
| Product Code: | JIX; |
| Panel: | Clinical Chemistry (75) |
ldentification of the Legally Marketed Device: 3. Siemens Calibrator B, K962041 (FSH, LH, Prolactin) Sicments Calibrati CalSet II , K992981 (Estradiol)
Device Descriptions: 4.
LOCI 8 CAL is a multi-analyte, liquid, frozen bovine serum albumin based product containing LOCT 8 CAL is a multi-analyte, liquid, frozen bovino oormone, recombinant human prolactin, estradiol, buffers and preservatives.
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Device Intended Uses: 5.
Dimension LOCI 8 Calibrator
The LOCI 8 is an in vitro diagnostic product for the calibration of the Prolactin (PRL), Luteinizing The LOCI 8 is an in vitro diagnostic product for the Calibration of the Production (PRO) (CONTRO Commone Vista® system.
Medical device to which equivalence is claimed and comparison information:
Californial California includent to Siemors Calibrator B and Roche Estradiol Ca 6. The LOCI 8 CAL is substantialy equivalent to Sements Culibricon of and for the local for the
ll. Like the predicates, LOCI 8 is an in vitro diagnostic product intended to be II. Like the predicates, LOCI o'ls an in MIFO diagnound provinsity of the president of
7. Comparative Features Table
| Feature | Predicate DeviceSiemens Calibrator B(K962041) | New DeviceDimension Vista® LOCI 8 CAL |
|---|---|---|
| SimilaritiesIntended Use: | Calibrator B is for in vitrodiagnostic use in thecalibration of the followingassays FSH, LH andProlactin. | LOCI 8 CAL is an in vitro diagnosticproduct for calibration of the folliclestimulating hormone (FSH),luteinizing hormone (LH) and prolactin(PRL). |
| Constituents: | FSH, LH, Prolactin. | FSH, LH, prolactin, |
| Traceability ofconstituents: | FSHLHProlactin | FSH - WHO 1st IS for FSH 92/510LH - WHO 2nd IS for LH 80/552Prolactin - WHO 3rd IS for PRL 84/500 |
| DifferencesIntended Use | Calibrator B is for use on theADVIA Centaur® or ACS:180 | LOCI 8 CAL is for use on theDimension Vista® System. |
| systemsCalibrator B is also used forthe calibration of digoxin,Total IGE, Total hCG and | LOCI 8 Calibrator is also used forestradiol (E2). | |
| Form | TSHLyophilized equine serum | frozen liquid, bovine serum albumin |
| Traceability ofConstituents | Estradiol - Isotope Dilution gaschromatography mass spectroscopyreference measurement procedure | |
| Levels:Stability and | 2Calibrator B is stored at 2 - 8 ° | 5LOCI 8 CAL is stored at - 25 to -15 ° |
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° C. storage
C.
Calibrator B is stable, Calibratituted for 28 days @ 2 - 8 ° C.
LOCI 8 CAL is stable, thawed and LOCT o CAL is stable, the stable, to a ° C.
unopened for 8 days @ 2 – 8 ° C.
| Feature | Predicate DeviceRoche - Estradiol II CalSet II(K992681) | New DeviceDimension Vista® LOCI 8 CAL |
|---|---|---|
| SimilaritiesIntended Use: | Elecsys Estradiol II CalSet IIis an in vitro diagnosticproduct used for calibrating aquantitative estradiol assay. | LOCI 8 CAL is an in vitro diagnosticproduct for calibration of aquantitative estradiol assay. |
| Constituents: | Estradiol | Estradiol |
| Traceability ofconstituents: | The Elecsys Estradiol IIassay has been standardizedusing ID-GC/MS (isotopedilution-gas chromatography). | The E2 assay on the DimensionVista® has been standardized usingID-GC/MS (isotope dilution-gaschromatography). |
| DifferencesIntended Use | The Elecsys Estradiol IICalSet II is for use on theElecsys and cobas eimmunoassay analyzers.The Elecsys Estradiol IICalSet II is for use only in thecalibration of Estradiol II. | LOCI 8 CAL is for use on theDimension Vista® System.LOCI 8 Calibrator is also used for thecalibration of follicle stimulatinghormone (FSH), luteinizing hormone(LH) and prolactin (PRL). |
| Form | Lyophilized human serum | frozen liquid, bovine serum albumin |
| Levels:Stability andstorage | 2Elecsys Estradiol II CalSet IIis stored at 2-8 °C. | 5LOCI 8 CAL is stored at - 25 to -15 °C. |
| Elecsys Estradiol II CalSet IIis stable, reconstituted threemonths when stored at - 20 °C. | LOCI 8 CAL is stable, thawed andunopened for 8 days @ 2 – 8 °C |
Conclusion 8.
LOCI 8 CAL, is substantially equivalent in intended use to the legally marketed devices, Siemens
, Sales (1200011) and Roobe — Estradiol II CalSet II (K992981) based on the LOCI 8 CAL, is substantially equivalent in intended use to the legally managed with in the information
Calibrator B (K962041) and Roche – Estradiol II CalSet II (K992981) bas described above.
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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 tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
Siemens Healthcare Diagnostics, Inc. c/o Ms. Anna Marie Ennis Senior Regulatory Affairs & Compliance Specialist 500 GBC Drive, PO Box 6101 Newark, Delaware 19714-61015
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Re: K101460
Trade Name: Loci 8 Calibrator, Model KC 646 Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIX Dated: May 25, 2010 Received: May 26, 2010
JUL 0 9 2010
Dear Ms. Ennis:
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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Page 2
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/MedicalDevices/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,
CFC
Courtney C. Harper, Ph.D. Directør 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 Form
510(k) Number (if known): _K \ O \ 님 O
LOCI 8 CAL Device Name:
LOCI 8 CAL is an in vitro diagnostic product for the calibration Indications for Use: of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL) and estradiol (E2)methods on the Dimension Vista® Systems .
Over-The-Counter Use XX Prescription Use AND/OR (21 CFR 801 Subpart C) Freschplion 2001 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER ()
CONTINUE CONTINUE BASE OF NEEDED) PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benaim
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101460
Page 1 of
§ 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.