(196 days)
Not Found
No
The description details a standard immunoassay based on a competition principle and electrochemiluminescence detection, with results determined by a calibration curve. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an immunoassay used for the quantitative determination of autoantibodies to TSH receptor in human serum to assess patients with suspected Graves' disease. It is a diagnostic tool, not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the immunoassay is used for "quantitative determination of autoantibodies to TSH receptor in human serum" and "in the assessment of patients with suspect Graves' disease," which are diagnostic purposes.
No
The device is an immunoassay and quality control material, which are physical reagents used with immunoassay analyzers. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Elecsys Anti-TSHR immunoassay is for the "in vitro quantitative determination of autoantibodies to TSH receptor in human serum". The term "in vitro" is a key indicator of an IVD, meaning it's used to test samples outside of the living body.
- Sample Type: The assay is performed on "human serum", which is a biological sample taken from a patient.
- Purpose: The assay is used "in the assessment of patients with suspect Graves' disease", indicating its use in diagnosing or monitoring a medical condition.
- Device Description: The description details an "immunoassay" which is a common type of IVD test.
- Quality Control: The inclusion of "Elecsys PreciControl ThyroAB" for "quality control of the Elecsys Anti-TSHR immunoassay" further supports its role as a diagnostic test requiring quality assurance.
N/A
Intended Use / Indications for Use
- (1) Elecsys Anti-TSHR immunoassay: Immunoassay for the in vitro quantitative determination of autoantibodies to TSH receptor in human serum using a human thyroid stimulating monoclonal antibody. The anti-TSH receptor determination is used in the assessment of patients with suspect Graves' disease (autoimmune hyperthyroidism). The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
- (2) Elecsys PreciControl ThyroAB is used for quality control of the Elecsys Anti-TSHR immunoassay on the Elecsys and cobas e immunoassay analyzers.
Product codes
JZO, JJX
Device Description
- (1) The Elecsys Anti-TSHR immunoassay is a three step competition principle immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.
- (2) The Elecsys PreciControl ThyroAB is a lyophilized product consisting of human serum with added Anti-TSHR antibody (human) in two concentration ranges. During manufacture, the antibody is spiked into the matrix at the desired concentration levels. Note: The reagent and quality control material are packaged separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human serum
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)
Method Comparison:
A comparison of the Elecsys Anti-TSHR assay (y) with BRAHMS LUMItest TRAK human (x) using clinical samples gave the following correlations:
Number of samples measured: 212
Sample concentrations were between 1.1 IU/L and 40.0 IU/L
Passing/Bablok: 95% CI: $y = 1.183x - 0.316$ Slope = 1.11 - 1.27 Intercept = -0.633 to -0.079
Concordance:
Commercial anti-TSHR:
1.75 IU/L (7), Elecsys Anti-TSHR 1.75 IU/L (11), Elecsys Anti-TSHR 2.0 IU/L: Elecsys Anti-TSHR >1.75 IU/L (199), Elecsys Anti-TSHR 2.0 IU/L)
a. 42 results were excluded from the calculations after giving indeterminate results on the comparative method. A more differentiated analysis of the samples which gave indeterminate results in the comparative method shows that: 2 of the 11 samples positive with Elecsys Anti-TSHR have values from 1.75 – 2 IU/L, 9 of the 11 samples positive with Elecsys Anti-TSHR have values above 2 IU/L, 11 of the 31 samples negative with Elecsys Anti-TSHR have values below 1 IU/L and 20 of the 31 samples negative with Elecsys Anti-TSHR have values from 1 – 1.75 IU/L.
Agreement Classification % Agreement (%)b 95% CI (%)
Neg. Agreement Elecsys Anti-TSHR: 102/109, 93.6%, 87.2 to 97.4
Pos. Agreement Elecsys Anti-TSHR: 199/199, 100%, 98.2 to 100
b. % positive of Elecsys Anti-TSHR among indeterminate results of comparative method equals 26.2% (11/42). % negative of Elecsys Anti-TSHR among indeterminate results of comparative method equals 73.8% (31/42).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Precision and analytical sensitivity provided in the document:
Precision:
Elecsys 2010 and cobas e 411:
Within-run:
5.9% CV @ 1.73 IU/L
4.4% CV @ 2.57 IU/L
2.7% CV @ 6.57 IU/L
1.3% CV @ 25.5 IU/L
3.0% CV @ 3.60 IU/L
1.7% CV @ 15.0 IU/L
Total:
9.7% CV @ 1.73 IU/L
6.7% CV @ 2.57 IU/L
3.9% CV @ 6.57 IU/L
1.8% CV @ 25.5 IU/L
5.1% CV @ 3.60 IU/L
2.4% CV @ 15.0 IU/L
E170 and cobas e 601:
Within-run:
7.6% CV @ 1.71 IU/L
5.1% CV @ 2.16 IU/L
1.9% CV @ 5.92 IU/L
0.9% CV @ 24.6 IU/L
3.1% CV @ 3.16 IU/L
1.4% CV @ 14.6 IU/L
Total:
11.4% CV @ 1.71 IU/L
8.7% CV @ 2.16 IU/L
3.8% CV @ 5.92 IU/L
1.9% CV @ 24.6 IU/L
5.5% CV @ 3.16 IU/L
2.4% CV @ 14.6 IU/L
Limit of Blank (LoB):
§ 866.5870 Thyroid autoantibody immunological test system.
(a)
Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.(b)
Classification. Class II (performance standards).
0
Kosoog2
| 510(k) Summary | 'JUL 2 8 2008 |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
| Submitter name, address, contact | Roche Diagnostics |
| 9115 Hague Road | |
| Indianapolis, IN 46250 |
Contact person: Stephanie Greeman
Phone: (317) 521-2458
FAX: (317) 521-2324
email: stephanie.greeman@roche.com
• Secondary contact :
Kay Taylor
• Phone: (317) 521-3544
• FAX: (317) 521-2324
• email: kay.taylor@roche.com
Date Prepared: June 17, 2008 |
| Device Name | Proprietary name: (1) Elecsys Anti-TSHR Immunoassay
(2) Elecsys PreciControl ThyroAB
Common name: (1) Anti-TSHR Assay
(2) PreciControl ThyroAB
Classification name: (1) System, Test, Thyroid Autoantibody
(2) Single (specified) analyte controls (Assayed and Unassayed) |
| Device
Description | (1) The Elecsys Anti-TSHR immunoassay is a three step competition
principle immunoassay with streptavidin-coated microparticles and
electrochemiluminescence detection. Results are determined using a
calibration curve that is generated specifically on each instrument by a 2 point
calibration and a master curve provided with the reagent bar code.
(2) The Elecsys PreciControl ThyroAB is a lyophilized product consisting of
human serum with added Anti-TSHR antibody (human) in two concentration
ranges. During manufacture, the antibody is spiked into the matrix at the
desired concentration levels.
Note: The reagent and quality control material are packaged separately. |
| Intended use /
Indications for
Use | (1) Elecsys Anti-TSHR immunoassay: Immunoassay for the in vitro
quantitative determination of autoantibodies to TSH receptor in human serum
using a human thyroid stimulating monoclonal antibody. The anti-TSH
receptor determination is used in the assessment of patients with suspect
Graves' disease (autoimmune hyperthyroidism).
The electrochemiluminescence immunoassay "ECLIA" is intended for use on
Elecsys and cobas e immunoassay analyzers.
(2) Elecsys PreciControl ThyroAB is used for quality control of the Elecsys
Anti-TSHR immunoassay on the Elecsys and cobas e immunoassay
analyzers. |
| Substantial
equivalence | The Elecsys Anti-TSHR Test System is substantially equivalent to the
following cleared device:
(1) Elecsys Anti-TSHR Immunoassay is equivalent to the BRAHMS
LUMItest TRAK human Assay (K033454). Both products are intended for
use in the quantitative determination of autoantibodies to TSH receptor in
human serum.
(2) Elecsys PreciControl ThyroAB is equivalent to the controls contained in
the BRAHMS LUMItest TRAK human Assay Kit (K033454). |
:
.
Continued on next page
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2
The following table compares the Elecsys Anti-TSHR Immunoassay with the Substantial predicate device. equivalence comparison
| Immunoassay Comparison | ||
|---|---|---|
| Feature | Elecsys Anti-TSHR Assay | Predicate Device |
| BRAHMS LUMItest TRAK human | ||
| Assay (K033454) | ||
| Intended Use | Immunoassay for the in vitro | |
| quantitative determination of | ||
| autoantibodies to TSH receptor in | ||
| human serum using a human thyroid | ||
| stimulating monoclonal antibody. | ||
| The anti-TSH receptor | ||
| determination is used in the | ||
| assessment of patients with suspect | ||
| Graves' disease (autoimmune | ||
| hyperthyroidism). | ||
| The electrochemiluminescence | ||
| immunoassay “ECLIA” is intended | ||
| for use on Elecsys and cobas e | ||
| immunoassay analyzers. | Luminescence receptor assay (LRA) | |
| for the quantitative determination of | ||
| antibodies to the human thyrotropin | ||
| (TSH) receptor. | ||
| Indication for | ||
| Use | See intended use. | The measurement of TSH receptor |
| autoantibodies is used in the | ||
| assessment of patients with suspect | ||
| Graves' disease (autoimmune | ||
| hyperthyroidism). | ||
| Assay Protocol | Competition principle | same |
| Detection | ||
| Protocol | electrochemiluminescence | |
| immunoassay (ECLIA) | Luminescence receptor assay (LRA) | |
| Traceability/ | ||
| Standardization | Standardized against NIBSC 1st IS | |
| 90/672 Standard | WHO 1st International reference | |
| material, 90/672 for TSAb | ||
| Calibration | ||
| Interval | • Daily | |
| • As required: e.g. quality control | ||
| findings outside the specified | ||
| limits | N/A | |
| Sample Type | Human serum | same |
| Immunoassay Comparison, continued | ||
| Feature | Elecsys Anti-TSHR Assay | Predicate Device |
| BRAHMS LUMItest TRAK human | ||
| Assay (K033454) | ||
| Reagent Stability | Unopened up to the stated | |
| expiration date stored at 2 – 8°C | ||
| • On the analyzer: 72 hours if | ||
| continuously stored onboard; or 2 | ||
| weeks including up to 56 hours in | ||
| total onboard if stored alternately | ||
| in the refrigerator and on the | ||
| analyzer | N/A | |
| Calibrator | Anti-TSHR calibrators 1 and 2 | |
| supplied with kit | TRAK standards supplied with kit | |
| Controls | Elecsys PreciControl ThyroAB | TRAC controls I and II supplied with |
| kit | ||
| Pretreatment | Pretreatment 1: buffer solution | |
| Pretreatment 2: empty bottle for | ||
| pretreatment reagent (PTR) | ||
| reconstituted with pretreatment | ||
| buffer (PTB) |
PTR: pretreatment reagent
PTB: pretreatment buffer | Buffer for incubation of samples
Buffer for reconstitution of tracer
Tracer: luminescence-labeled b-TSH |
| Expected Values | Positive: > 1.75 IU/L | Negative: 2 IU/L |
| Instrument | Elecsys 2010, MODULAR
ANALYTICS E170, cobas e 411,
cobas e 601 | Luminometer |
| Measuring
Range | 0.8 – 40 IU/L (defined by the limit
of detection and the maximum of
the master curve) | 0.9 – 40 IU/L |
| Feature | Immunoassay Performance Comparison
Elecsys Anti-TSHR Assay | Predicate Device
BRAHMS LUMItest TRAK human
Assay (K033454) |
| Precision | Elecsys 2010 and cobas e 411:
Within-run
5.9% CV @ 1.73 IU/L
4.4% CV @ 2.57 IU/L
2.7% CV @ 6.57 IU/L
1.3% CV @ 25.5 IU/L
3.0% CV @ 3.60 IU/L
1.7% CV @ 15.0 IU/L
Total
9.7% CV @ 1.73 IU/L
6.7% CV @ 2.57 IU/L
3.9% CV @ 6.57 IU/L
1.8% CV @ 25.5 IU/L
5.1% CV @ 3.60 IU/L
2.4% CV @ 15.0 IU/L
E170 and cobas e 601:
Within-run
7.6% CV @ 1.71 IU/L
5.1% CV @ 2.16 IU/L
1.9% CV @ 5.92 IU/L
0.9% CV @ 24.6 IU/L
3.1% CV @ 3.16 IU/L
1.4% CV @ 14.6 IU/L
Total
11.4% CV @ 1.71 IU/L
8.7% CV @ 2.16 IU/L
3.8% CV @ 5.92 IU/L
1.9% CV @ 24.6 IU/L
5.5% CV @ 3.16 IU/L
2.4% CV @ 14.6 IU/L | Interassay Precision:
Sample means 0.6 IU/L – 20.3 IU/L =
%CV 4.1 – 35.1%
Intra-assay Precision:
Sample means 0.9 IU/L – 101.7 IU/L =
% CV 2.3 – 24.2% |
のお気になる。
3
The following table compares the Elecsys Anti-TSHR Immunoassay with the Substantial equivalence predicate device. comparison
4
The following table compares the performance of Elecsys Anti-TSHR Substantial Immunoassay with the predicate device. equivalence comparison
5
The following table compares the performance of Elecsys Anti-TSHR Substantial Immunoassay with the predicate device. equivalence -
comparison
| Immunoassay Performance Comparison, continued | ||
|---|---|---|
| Feature | Elecsys Anti-TSHR Assay | Predicate Device |
| BRAHMS LUMItest TRAK human Assay (K033454) | ||
| LoQ | 0.9 IU/L | 0.9 IU/L |
| Limit of Blank | ||
| (LoB) | ≤0.5 IU/L | 0.4 IU/L |
| Limit of Detection LoD | ||
| (Analytical Sensitivity) | ≤0.8 IU/L | NA |
| Analytical Specificity | No interference with: | |
| Anti-TG if less than 4000 IU/mL Anti-TPO if less than 600 IU/mL Human TSH if less than 1000 mIU/L Human LH if less than 10,000 mIU/mL Human FSH if less than 10,000 mIU/mL hCG if less than 50,000 mIU/mL | No interference with : | |
| Anti-TG if less than 2000 U/mL Anti-TPO if less than 3000 U/mL Human TSH if less than 1000 mU/L Human LH if less than 9000 U/L Human FSH if less than 15,000 U/L |
6
The following table compares the performance of Elecsys Anti-TSHR Substantial Immunoassay with the predicate device. equivalence comparison
| Feature | Elecsys Anti-TSHR Assay | Predicate Device
BRAHMS LUMItest TRAK human Assay (K033454) |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Limitations | The assay is unaffected by:
Bilirubin: 10 ng/mL In patients receiving therapy with high biotin doses (i.e. >5 mg/day), no sample should be taken until at least 8 hours after the last biotin administration. No interference was observed from rheumatoid factors up to a concentration of 600 IU/mL | Hemoglobin:
Concentrations: Not given
Recovery: 100 – 125% Bilirubin:
Concentrations: 0.625, 1.25, 2.5, 5, 10, 20 mg/dL
Recovery: 91 – 100% Lipids:
Concentration: dilutions prepared off of 634 mg/dL lipemic serum
Recovery: 76 – 100% |
| Substantial
equivalence –
comparison | The following table compares the performance of Elecsys Anti-TSHR
Immunoassay with the predicate device. | |
| Immunoassay Performance Comparison, continued | | |
| | Elecsys Anti-TSHR Assay | Predicate Device
BRAHMS LUMItest TRAK human
Assay (K033454) |
| Limitations, continued | In vitro tests were performed on 20 commonly used pharmaceuticals. No interference with the assay was found except for heparin. In samples containing heparin elevated results are obtained. The risk of interference from potential immunological interactions between test components and rare sera has been minimized by the inclusion of suitable additives. In rare cases, interference due to extremely high titers of antibodies to streptavidin and ruthenium can occur. For diagnostic purposes, the results should always be assessed in conjunction with the patients medical history, clinical examination and other findings. | |
7
8
The following table compares the performance of Elecsys Anti-TSHR Substantial Immunoassay with the predicate device. equivalence comparison
| Feature | Elecsys Anti-TSHR Assay | Predicate Device
BRAHMS LUMItest TRAK human
Assay (K033454) | | | | | | | | | | | | | | | | | | | | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Method
Comparison | A comparison of the Elecsys Anti-TSHR
assay (y) with BRAHMS LUMItest TRAK
human (x) using clinical samples gave the
following correlations:
Number of samples measured: 212
Sample concentrations were between 1.1
IU/L and 40.0 IU/L
Passing/Bablok: 95% CI:
$y = 1.183x - 0.316$ $Slope = 1.11 - 1.27$
$Intercept = -0.633 to -0.079$
Concordance:
Commercial anti-TSHR Elecsys Anti-TSHR 2.0 IU/L >1.75 IU/L 7 11 199 ≤1.75 IU/L 102 31 0 total 109 42 199 a. 42 results were excluded from the
calculations after giving indeterminate results
on the comparative method. A more
differentiated analysis of the samples which
gave indeterminate results in the comparative
method shows that: 2 of the 11 samples
positive with Elecsys Anti-TSHR have values
from 1.75 – 2 IU/L, 9 of the 11 samples
positive with Elecsys Anti-TSHR have values
above 2 IU/L, 11 of the 31 samples negative
with Elecsys Anti-TSHR have values below 1
IU/L and 20 of the 31 samples negative with
Elecsys Anti-TSHR have values from 1 – 1.75
IU/L. | | | | | | | | | | | | | | | | | | | | | A correlation study was performed
between the predicate KRONUS
TRAb assay and the LUMItest TRAK
assay. Fifty-two (52) serum samples
obtained from either confirmed
Graves' disease patients or patients
with non-Graves' thyroid disease were
tested in parallel. Overall agreement
between the two assays was 75.0%. |
| | Agreement
Classification %
Agreement
(%)b 95%
CI (%) Neg.
Agreement 102/
109 93.6% 87.2 to
97.4 Pos.
Agreement 199/
199 100% 98.2 to
100 b. % positive of Elecsys Anti-TSHR among
indeterminate results of comparative method
equals 26.2% (11/42). % negative of Elecsys
Anti-TSHR among indeterminate results of
comparative method equals 73.8% (31/42). | | | | | | | | | | | | | | | | | | | | | |
9
The following table compares the calibrators supplied with the Elecsys Anti-Substantial equivalence -TSHR immunoassay kit with the calibrators supplied with the predicate comparison device.
| Calibrator Comparison | ||
|---|---|---|
| Feature | Elecsys Anti-TSHR Assay | Predicate Device |
| BRAHMS LUMItest TRAK human Assay (K033454) | ||
| Levels | 2 | 6 |
| Format | Lyophilized | N/A |
| Matrix | human serum | same |
| Analyte | ||
| Concentration | ||
| (Anti-TSHR | ||
| antibody; | ||
| human) | Calibrator 1: 1.0 IU/L | |
| Calibrator 2: 25 IU/L | Calibrator 1: 0 IU/L | |
| Calibrator 2: 1 IU/L | ||
| Calibrator 3: 2 IU/L | ||
| Calibrator 4: 4 IU/L | ||
| Calibrator 5: 16 IU/L | ||
| Calibrator 6: 40 IU/L | ||
| Stability | Unopened: | |
| • Store at 2 – 8°C until expiration date. | ||
| Reconstituted: | ||
| • On the analyzers at 20 – 25°C: up to 3 hours | ||
| • At -20°C: up to 3 months (freeze only once. | ||
| • After thawing: use only once. | N/A |
10
The following table compares the calibrators supplied with the Elecsys Anti-Substantial TSHR immunoassay kit with the calibrators supplied with the predicate equivalence comparison device.
| Calibrator Comparison, continued | ||
|---|---|---|
| Feature | Elecsys Anti-TSHR Assay | Predicate Device |
| BRAHMS LUMItest TRAK human | ||
| Assay (K033454) | ||
| Handling | Dissolve contents of one bottle by | |
| adding exactly 2.0 mL of distilled | ||
| water and allow to stand closed for | ||
| 15 minutes to reconstitute. Mix | ||
| carefully, avoiding the formation of | ||
| foam. | ||
| Transfer aliquots of freshly | ||
| reconstituted controls into empty | ||
| labeled snap-cap bottles. Attach the | ||
| supplied labels to the additional | ||
| bottles. Store the aliquots | ||
| immediately at -20°C. Perform | ||
| only one calibration procedure per | ||
| aliquot | N/A |
11
The following table compares the Elecsys PreciControl ThyroAB with the Substantial predicate device. equivalence comparison
| Control Comparison | ||
|---|---|---|
| Characteristic | Elecsys PreciControl ThyroAB | Predicate Device |
| BRAHMS LUMItest TRAK | ||
| human Assay (K033454) | ||
| Intended Use | Used for quality control of the | |
| Elecsys Anti-TSHR immunoassay | ||
| on the Elecsys and cobas e | ||
| immunoassay analyzers. | N/A | |
| Levels | Two | same |
| Format | Lyophilized | N/A |
| Matrix | Human serum | same |
| Stability | Unopened: | |
| • Store at 2 – 8°C until expiration | ||
| date. | ||
| Reconstituted: | ||
| • On the analyzers at 20 – 25°C: up | ||
| to 3 hours | ||
| • At -20°C: up to 3 months (freeze | ||
| only once. | ||
| • After thawing: use only once. | N/A | |
| Analyte | ||
| Concentration | ||
| PC 1 | 4 IU/L Anti-TSHR antibody (human) | Negative, indeterminate |
| (actual concentration not given) | ||
| Analyte | ||
| Concentration | ||
| PC 2 | 16 IU/L Anti-TSHR antibody | |
| (human) | Positive | |
| (actual concentration not given) |
12
The following table compares the Elecsys PreciControl ThyroAB with the Substantial predicate device. equivalence comparison
| Control Comparison, continued | ||
|---|---|---|
| Characteristic | Elecsys PreciControl ThyroAB | Predicate Device |
| BRAHMS LUMItest TRAK human Assay (K033454) | ||
| Handling | Dissolve contents of one bottle by | |
| adding exactly 2.0 mL of distilled | ||
| water and allow to stand closed for | ||
| 15 minutes to reconstitute. Mix | ||
| carefully, avoiding the formation of | ||
| foam. | ||
| Transfer aliquots of freshly | ||
| reconstituted controls into empty | ||
| labeled snap-cap bottles. Attach the | ||
| supplied labels to the additional | ||
| bottles. Store the aliquots | ||
| immediately at -20°C. Perform only | ||
| one control procedure per aliquot. | N/A |
13
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A."
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Corp. c/o Ms. Stephanie Greeman Regulatory Affairs Consultant 9115 Hague Road Box 50416 Indianapolis, IN 46250-0416
JUL 2 8 2008
Re: K080092
Trade/Device Name: Elecsys Anti-HSHR Immunoassay Elecsys PreciControl ThyroAB Regulation Number: 21 CFR 866.5870 Regulation Name: Thyroid autoantibody immunological test system Regulatory Class: Class II Product Code: JZO, JJX Dated: June 17, 2008 Reccived: June 19, 2008
Dear Ms. Greeman:
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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding
14
Page 2 -
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 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 (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Maria M. Chan
Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
15
Indication for Use – Elecsys Anti-TSHR Immunoassay
K 080092 510(k) Number (if known):
Device Name: Elecsys Anti-TSHR Immunoassay
Indication For Use:
Immunoassay for the in vitro quantitative determination of autoantibodies to TSH receptor in human serum using a human thyroid stimulating monoclonal antibody. The anti-TSH receptor determination is used in the assessment of patients with suspect Graves' disease (autoimmune hyperthyroidism).
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Prescription Use XXX (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Maria M Elon
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Kof 0092
16
Indication for Use - Elecsys PreciControl ThyroAB
510(k) Number (if known):
): K080092
Device Name: Elecsys PreciControl ThyroAB
Indication For Use:
Elecsys PreciControl ThyroAB is used for quality control of the Elecsys Anti-TSHR immunoassay on the Elecsys and cobas e immunoassay analyzers.
Prescription Use _ XXX (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Mana m Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080092