(35 days)
Not Found
No
The 510(k) summary describes a calibrator, which is a reagent used to calibrate an in vitro diagnostic system. There is no mention of AI or ML in the intended use, device description, or any other section. The device is a chemical product, not a software or imaging device that would typically incorporate AI/ML.
No
This device is an in vitro diagnostic product used for calibration of laboratory tests, not for treating any medical condition.
No
This device is described as an "in vitro diagnostic product for the calibration of the FT4L and TSHL methods." It is a calibrator, meaning it helps ensure the accuracy of diagnostic tests by providing a known standard, but it does not directly diagnose a condition itself.
No
The device description clearly states it is a liquid, bovine serum albumin based product, 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 Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L and TSHL methods on the Dimension® EXL™ with LM system."
This statement directly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The LOCI Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L and TSHL methods on the Dimension® EXL™ with LM system.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
The LOCI Thyroid Calibrator is a liquid, bovine serum albumin based product containing thyroid stimulating hormone and thyroxine.
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)
The stability of the calibrators is established through real-time data on 3 lots of product. Testing is conducted at multiple time points and must pass pre-defined acceptance criteria.
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 of Safety and Effectiveness LOCI Thyroid Calibrator
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation
Siemens Healthcare Diagnostics Inc. Manufacturer: P.O. Box 6101 Newark, DE 19714
Contact Information: Siemens Healthcarc Diagnostics Inc. P.O. Box 6101 Newark, DE 19714 Attn: Yuk-Ting Lewis Tel: 302-631-7626
Date of Preparation: April 14, 2008
2. Devicc Name / Classification
LOC1 Thyroid Calibrator / 21 CFR 862.1150 / Class 11
Identification of the Predicate Device 3.
LOCI Thyroid Calibrator, K073604
4. Device Description
The LOCI Thyroid Calibrator is a liquid, bovine serum albumin based product containing thyroid stimulating hormone and thyroxine. The calibrator levels and their assigned values are:
| | evel | .
Level 3 | LA MARKE
Level | Level | Level |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|--------------|-----------------------------------------------------------------------------------------------------------------|------------|---------------|
| 135 11
The Property of the Production of the Property of the Production of the Production of the Production of the Production of the Property of Property of Property of Property of | | ng | no
C
- 24 ----
A minimum a come of the a fine of the of the of the of the one of the one of the county | ng | no/
i - |
| . TEU' | | .
1877 | 4,555 | ﺎ ﮐﺎ
00 | -------- |
1
ട്. Device Intended Use
The LOCI Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L and TSHL methods on the Dimension® EXL™ with LM system.
.b Medical device to which equivalence is claimed and comparison information
The LOCI Thyroid Calibrator is substantially equivalent to the calibrator previously cleared under K073604. The LOCl Thyroid Calibrator contains human thyroid stimulating hormone and thyroxinc for calibrating the Dimension® TSHL and FT4L methods.
| Feature | Predicate Device:
LOCI Thyroid Calibrator | New Device:
LOCI Thyroid Calibrator |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LOCI Thyroid Calibrator is
used to calibrate the
Dimension® FT4L method on
the Dimension® EXL™ with
LM system. | The LOCI Thyroid Calibrator is
used to calibrate the
Dimension® FT4L and TSHL
methods on the Dimension®
EXLT™ with LM system. |
| Analyte and Matrix | The LOCI Thyroid Calibrator
contains thyroxine in a bovine
serum albumin matrix. | The LOCI Thyroid Calibrator
contains human thyroid
stimulating hormone and
thyroxine in a bovine serum
albumin matrix. |
| Form | The calibrators are in liquid form. | |
| Calibrator levels | The LOCI Thyroid Calibrator
kit contains Levels 3 through 6. | The LOCI Thyroid Calibrator
kit contains Levels 2 through 6.
Levels 3 through 6 are used to
calibrate the FT4L method.
Levels 2 through 6 are used to
calibrate the TSHL method. |
| Stability | The stability of the calibrators is established through real-time data
on 3 lots of product. Testing is conducted at multiple time points
and must pass pre-defined acceptance criteria. | |
| Traceability | The calibrator is traceable to an
internal master pool for FT4. | The calibrator is traceable to an
internal master pool for FT4 and
to the WHO standard for TSH. |
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Image /page/2/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 eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 3 2008
Siemens Healthcare Diagnostics, Inc. c/o Yuk-Ting Lewis P.O. Box 6101, M/S 514 Newark, DE 19714
Re: K081103 Trade/Device Name: LOCI Thyroid Calibrator Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: May 13, 2008 Received: May 14, 2008
Dear Ms. Lewis:
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.
Jéan 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
4
Indication for Use
510(k) Number (if known):