OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM
Device Facts
| Record ID | K062581 |
|---|---|
| Device Name | OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM |
| Applicant | Olympus America, Inc. |
| Product Code | JLW · Clinical Chemistry |
| Decision Date | Nov 29, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1690 |
| Device Class | Class 2 |
Intended Use
The Olympus thyroid stimulating hormone (TSH) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of TSH levels in human serum and plasma using the Olympus AU3000i™ Immunoassay System. Measurements of TSH produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The Olympus TSH Calibrator is used for calibrating the quantitative Olympus TSH Assay on the Olympus AU3000i Immunoassay System. The Olympus TSH Control is used for quality control of the Olympus TSH test system on the Olympus AU3000i Immunoassay System. The Olympus AU3000i Immunoassay System is a chemiluminescent discrete photometric chemistry analyzer for the quantitative determination of analytes in human serum and plasma.
Device Story
The Olympus TSH Test System is a two-step paramagnetic particle enzyme immunoassay performed on the Olympus AU3000i Immunoassay System. Input: human serum or plasma samples. Operation: samples incubate with monoclonal anti-TSH antibody-coated paramagnetic particles; a second alkaline phosphatase-conjugated anti-TSH antibody is added to form a sandwich complex; unbound material is washed away. A chemiluminescent substrate reacts with the bound alkaline phosphatase; the resulting light emission is measured by a luminometer. Output: TSH concentration in mIU/L or µIU/mL, calculated via a pre-defined calibration curve. Used in clinical laboratory settings by trained personnel. The system provides automated, high-throughput (240 results/hour) quantitative analysis to assist clinicians in diagnosing thyroid or pituitary disorders.
Clinical Evidence
Bench testing only. Precision evaluated per CLSI EP05-A2 (n=80, CVs 2.2-6.0%). Linearity/recovery assessed across 0.001-130 mIU/L range (mean recovery 93.68%). Analytical sensitivity (0.0002 mIU/L) and functional sensitivity (0.0013 mIU/L) established. Specificity testing showed no significant cross-reactivity with FSH, LH, or hCG. Interference testing confirmed robustness against bilirubin, hemoglobin, Intralipid, and rheumatoid factor. Method comparison (n=127) against predicate showed high correlation (r=0.9931). Matrix comparison validated serum, EDTA, and lithium heparin plasma.
Technological Characteristics
Two-step paramagnetic particle enzyme immunoassay. Reagents: murine monoclonal anti-TSH antibodies, alkaline phosphatase conjugate, Tris/MES buffers. Analyzer: Olympus AU3000i chemiluminescent discrete photometric chemistry analyzer. Energy: luminometer-based light detection. Connectivity: RS232C bidirectional host interface. Calibration: polygonal curve, max 16 master points. QC: Westgard multirule, Shewhart X-R. Software: automated calculation of TSH concentration.
Indications for Use
Indicated for the quantitative determination of TSH levels in human serum and plasma to aid in the diagnosis of thyroid or pituitary disorders. For use by clinical professionals on the Olympus AU3000i Immunoassay System.
Regulatory Classification
Identification
A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
Predicate Devices
- Roche Elecsys® TSH Assay (k961491)
- Roche Elecsys® TSH CalSet (k060754)
- Roche Elecsys® PreciControl TSH (k962573)
- Roche Elecsys® 2010 analyzer (k961481)
Submission Summary (Full Text)
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K062581
## 510(k) Summary
NOV 2 9 2006
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the
requirements of SMDA 1990 and 21 CFR 807.92.
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| 1. | Submitter name,<br>address, contact | Olympus America<br>3131 W Royal Lane<br>Irving, TX 75063<br><br>Telephone:<br>Fax:<br><br>Contact Person:<br>Date Prepared: | (972) 556-9697<br>(972) 556-0365<br><br>David Davis<br>October 6, 2006 |
|----|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Device name | Proprietary Name:<br><br>Common Name:<br><br>Classification Name: | Olympus TSH Reagent<br>Olympus TSH Calibrator<br>Olympus TSH Control<br>Olympus AU3000i™ Immunoassay System<br><br>TSH Reagent, Calibrator & Control<br>Immunoassay Analyzer<br><br>Thyroid-Stimulating Hormone Test System,<br>Calibrator, secondary<br>Single (specified) analyte control (assayed and<br>unassayed)<br>Analyzer, Chemistry (Photometric, Discrete),<br>For Clinical Use |
| 3. | Predicate device | Reagent:<br><br>Calibrator:<br><br>Control:<br><br>Analyzer: | Roche Elecsys® TSH Assay (K961491)<br><br>Roche Elecsys® TSH CalSet (K060754)<br><br>Roche Elecsys® PreciControl TSH (K962573)<br><br>Roche Elecsys® 2010 analyzer (K961481) |
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| 4. | Device description | The Olympus TSH assay is a two-step paramagnetic particle enzyme<br>immunoassay. It is based on the sandwich principle and used to quantitate<br>TSH in serum/plasma. | | |
|----|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | | The Olympus TSH assay reagent and sample are added to the assay<br>cuvette in the following sequence: | | |
| | | 1. Samples are incubated first with a monoclonal anti-TSH antibody<br>bound to paramagnetic particles.<br>2. After a washing step, a second monoclonal anti-TSH antibody<br>conjugated with alkaline phosphatase is added. The TSH reacts with<br>the paramagnetic particles and the conjugated antibody to form a<br>sandwich complex. Washing steps remove the unbound material. | | |
| | | 3. The chemiluminescent substrate is added to the assay cuvette and<br>reacts with the bound alkaline phosphatase (ALP). Light generated<br>by the reaction is measured by the luminometer. The light emission is<br>proportional to the quantity of TSH in the sample.<br>4. Results are calculated from a pre-defined calibration curve. The | | |
| | | Olympus AU3000i system automatically calculates the TSH<br>concentration of each sample in mIU/L or µIU/mL. | | |
| 5. | Intended use | The Olympus thyroid stimulating hormone (TSH) assay is a paramagnetic<br>particle, chemiluminescent immunoassay for the quantitative<br>determination of TSH levels in human serum and plasma using the<br>Olympus AU3000i™ Immunoassay System. | | |
| | | Measurements of TSH produced by the anterior pituitary are used in the<br>diagnosis of thyroid or pituitary disorders. | | |
| | | The Olympus TSH Calibrator is used for calibrating the quantitative<br>Olympus TSH Assay on the Olympus AU3000i Immunoassay System. | | |
| | | The Olympus TSH Control is used for quality control of the Olympus TSH<br>test system on the Olympus AU3000i Immunoassay System. | | |
| | | The Olympus AU3000i Immunoassay System is a chemiluminescent<br>discrete photometric chemistry analyzer for the quantitative determination<br>of analytes in human serum and plasma. | | |
:
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- 6. Comparison to
predicate device
The following tables compare the Olympus TSH Test System with the
Roche Elecsys® TSH Test System.
| Item | AU3000i with TSH | Roche Elecsys® TSH |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative determination of thyroid stimulating hormone (TSH) levels in human serum/plasma | Immunoassay for the in vitro quantitative determination of thyrotropin in human serum and plasma. |
| Traceability | WHO | WHO |
| Detection/Operating Principle | Chemiluminescence | Chemiluminescence |
| Assay Methodology | Sandwich immunoassay | Sandwich immunoassay |
| Solid Phase | Micro-particle | Micro-particle |
| Sample Type | Serum and plasma | Serum and plasma |
| Antibody | Monoclonal anti-TSH mouse antibody | Monoclonal anti-TSH mouse antibody |
| Analyzer Reagents | On-board Storage<br>Bar-coded (I-D & 2-D) reagent, calibrator & control<br>Cap/septum for increased reagent stability and evaporation control | On-board Storage<br>Bar-coded (1-D & 2-D) reagent, calibrator & control<br>Cap/septum for increased reagent stability and evaporation control |
| Reagent, Calibrator and Control storage form | Liquid | Liquid |
| Calibration and Control Stability | Unopened<br>• At 2-8°C up to the stated expiration date<br>Opened<br>• 28 days / 4 weeks at 2-8°C | Unopened<br>• At 2-8°C up to the stated expiration date<br>Opened<br>• 28 days / 4 weeks at 2-8°C |
| Control levels and target concentration range | One Euthyroid/Hyperthyroid threshold | One Euthyroid/Hyperthyroid threshold |
| Control constituents | Single | Single |
| Control Matrix | Human serum with added antigen | Human serum with added antigen |
| Analyzer System | Fully automated<br>Random access<br>Computer controlled<br>Stat capability | Fully automated<br>Random access<br>Computer controlled<br>Stat capability |
| Analyzer/User Interface | Keyboard/touch screen control<br>Colored touch screen monitor<br>Stationary barcode scanners<br>Graphical user interface<br>On line help | Keyboard/touch screen control<br>Colored touch screen monitor<br>Stationary barcode scanners<br>Graphical user interface<br>On line help |
| Analyzer Consumables | Disposable reaction vessels<br>Disposable sample tips | Disposable reaction vessels<br>Disposable sample tips |
| Analyzer Sample Detection | Liquid Level Detection<br>Clot Detection | Liquid Level Detection<br>Clot Detection |
| Analyzer Host Interface | RS232C bidirectional | RS232C bidirectional |
| | Differences | |
| Item | AU3000i with TSH | Roche Elecsys® TSH |
| Instrument Required | Olympus AU3000i™<br>Immunoassay System | Roche Elecsys and Modular<br>analytics immunoassay analyzers. |
| Traceability | WHO 3rd IS 81/565 | WHO 2nd IRP 80/558 |
| Calibrator levels and target<br>Concentration | One<br>Cal: 13 µIU/mL | Two<br>Cal 1: 0 µIU/mL<br>Cal 2: 1.5 µIU/Ml |
| Solid phase binding principle | Direct coating | Biotin and streptavidin |
| Assay Range | 0.001 – 130 µIU/mL | 0.005 – 100 µIU/mL |
| Calibrator Matrix | Bovine serum human pituitary<br>TSH | Horse serum with added<br>recombinant TSH |
| Analyzer Sample Volume | 10 – 100 µl | 10 – 50 µl |
| Analyzer Reagent Positions | 24 reagent positions<br>2 diluent/pretreatment positions | 15 reagent positions<br>2 diluent/pretreatment positions |
| Analyzer Throughput | 240 results/hour | 88 results/hour |
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| Performance Characteristics | | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Item | AU3000i with TSH | Roche Elecsys® TSH |
| Precision | Sample Total CV% | Sample Total CV% |
| | Low 2.9 | Low 8.7 |
| | Med 6.0 | Med 3.3 |
| | High 3.7 | High 3.6 |
| Functional Sensitivity | 0.0013 µIU/mL | 0.014 µIU/mL |
| Analytical Sensitivity | 0.0002 µIU/mL | 0.005 µIU/mL |
| Measurable Range | 0.001 – 130 µIU/mL | 0.005 – 100.0 µIU/mL |
| Method Comparison (Passing<br>Bablok) | Intercept-0.0046<br>Slope 0.935<br>R 0.9931 | Intercept0.01<br>Slope 1.01<br>R 0.944 |
| Applicable Interfering Substances | Bilirubin ≤ 10% @ 40 mg/dL<br>Hemolysis ≤ 5% @ 5 g/L<br>Lipemia ≤ 3% @ 10 g/L | Bilirubin ≤ 10% @ 41 mg/dL<br>Hemolysis ≤ 10% @ 1 g/dL<br>Lipemia ≤ 10% @ 1500 mg/dL |
| Specificity | LH No significant<br>interference<br>FSH No significant<br>interference<br>hGH Not Tested<br>hCG Not Detected | LH No significant<br>interference<br>FSH No significant<br>interference<br>hGH Not Detected<br>hCG Not Detected |
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Image /page/4/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol in the center appears to be an abstract representation of an eagle or bird, with three curved lines forming its body and wings.
Public Health Service
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Mr. David Davis Manager, RA/QA Olympus America, Inc. 3131 West Royal Lane Irving, TX 75063
NOV 2 9 2006
k062581 Re: Trade/Device Name: Olympus TSH (thyroid stimulating hormone) Test System and Olympus AU3000i™ Immunoassay System Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system ﻣﻌﺪﺩﺳﻤﺴ Regulatory Class: Class II Product Code: JLW, JIS, JJX, JJE Dated: August 28, 2006 Received: August 31, 2006
Dear Mr. Davis: ·
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 cither class II (Spccial 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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## Page 2 -
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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Albert Gutz
Alberto Gutierrez, Ph.D. 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
009581
**510(k) Number (if known):**
Device Name:
Olympus TSH (thyroid stimulating hormone) Test System and Olympus AU3000i™ Immunoassay System
## Indications for Use:
The Olympus thyroid stimulating hormone (TSH) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of TSH levels in human serum and plasma using the Olympus AU3000i™ Immunoassay System.
Measurements of TSH produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Olympus TSH Calibrator is used for calibrating the quantitative Olympus TSH Assay on the Olympus AU3000i Immunoassay System.
The Olympus TSH Control is used for quality control of the Olympus TSH test system on the Olympus AU3000i Immunoassay System.
The Olympus AU3000i Immunoassay System is a chemiluminescent discrete photometric chemistry analyzer for the quantitative determination of analytes in human serum and plasma.
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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