(44 days)
Not Found
No
The summary describes a calibrator product for in vitro diagnostic tests, which is a chemical reagent, not a software or hardware device that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an in vitro diagnostic product for calibration of hormone methods, not for treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that "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." Calibrators are essential for ensuring the accuracy and reliability of diagnostic tests, making this product part of the diagnostic process.
No
The device description clearly states it is a liquid, frozen product containing biological components, which is a physical substance, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that LOCI 8 CAL is an "in vitro diagnostic product".
- Function: The intended use describes its function as being for the "calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL) and estradiol (E2) methods on the Dimension Vista® Systems". Calibration is a crucial step in ensuring the accuracy of in vitro diagnostic tests.
- Device Description: The description mentions it's a "multi-analyte, liquid, frozen bovine serum albumin based product containing hormone, recombinant human prolactin, estradiol, buffers and preservatives." This composition is consistent with materials used in in vitro diagnostic procedures.
Therefore, the device's intended use and description clearly align with the definition of an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The LOCI 8 is an in vitro diagnostic product for the calibration of the Prolactin (PRL), Luteinizing (LH), Follicle Stimulating Hormone (FSH) and Estradiol (E2) methods on the Dimension Vista® system. 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.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
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.
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)
Not Found
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.
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
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.
1
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 Device
Siemens Calibrator B
(K962041) | New Device
Dimension Vista® LOCI 8 CAL |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities
Intended Use: | Calibrator B is for in vitro
diagnostic use in the
calibration of the following
assays FSH, LH and
Prolactin. | LOCI 8 CAL is an in vitro diagnostic
product for calibration of the follicle
stimulating hormone (FSH),
luteinizing hormone (LH) and prolactin
(PRL). |
| Constituents: | FSH, LH, Prolactin. | FSH, LH, prolactin, |
| Traceability of
constituents: | FSH
LH
Prolactin | FSH - WHO 1st IS for FSH 92/510
LH - WHO 2nd IS for LH 80/552
Prolactin - WHO 3rd IS for PRL 84/500 |
| Differences
Intended Use | Calibrator B is for use on the
ADVIA Centaur® or ACS:180 | LOCI 8 CAL is for use on the
Dimension Vista® System. |
| | systems
Calibrator B is also used for
the calibration of digoxin,
Total IGE, Total hCG and | LOCI 8 Calibrator is also used for
estradiol (E2). |
| Form | TSH
Lyophilized equine serum | frozen liquid, bovine serum albumin |
| Traceability of
Constituents | | Estradiol - Isotope Dilution gas
chromatography mass spectroscopy
reference measurement procedure |
| Levels:
Stability and | 2
Calibrator B is stored at 2 - 8 ° | 5
LOCI 8 CAL is stored at - 25 to -15 ° |
2
° 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 Device
Roche - Estradiol II CalSet II
(K992681) | New Device
Dimension Vista® LOCI 8 CAL |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities
Intended Use: | Elecsys Estradiol II CalSet II
is an in vitro diagnostic
product used for calibrating a
quantitative estradiol assay. | LOCI 8 CAL is an in vitro diagnostic
product for calibration of a
quantitative estradiol assay. |
| Constituents: | Estradiol | Estradiol |
| Traceability of
constituents: | The Elecsys Estradiol II
assay has been standardized
using ID-GC/MS (isotope
dilution-gas chromatography). | The E2 assay on the Dimension
Vista® has been standardized using
ID-GC/MS (isotope dilution-gas
chromatography). |
| Differences
Intended Use | The Elecsys Estradiol II
CalSet II is for use on the
Elecsys and cobas e
immunoassay analyzers.
The Elecsys Estradiol II
CalSet II is for use only in the
calibration of Estradiol II. | LOCI 8 CAL is for use on the
Dimension Vista® System.
LOCI 8 Calibrator is also used for the
calibration of follicle stimulating
hormone (FSH), luteinizing hormone
(LH) and prolactin (PRL). |
| Form | Lyophilized human serum | frozen liquid, bovine serum albumin |
| Levels:
Stability and
storage | 2
Elecsys Estradiol II CalSet II
is stored at 2-8 °C. | 5
LOCI 8 CAL is stored at - 25 to -15 °C. |
| | Elecsys Estradiol II CalSet II
is stable, reconstituted three
months when stored at - 20 °C. | LOCI 8 CAL is stable, thawed and
unopened 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.
3
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).
4
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
5
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