(142 days)
No
The summary describes a standard automated immunoassay system and assay kit, controlled by "custom and off-the-shelf software." There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies. The performance studies focus on standard analytical validation metrics for an immunoassay.
No
This device is an in vitro diagnostic (IVD) immunoassay system used for quantitative determination of TSH in human serum and plasma, which aids in the diagnosis of thyroid or pituitary disorders. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is an "immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens" and that measurements are "used in the diagnosis of thyroid or pituitary disorders."
No
The device description explicitly states it is a "floor model, fully automated, microprocessor-controlled, integrated instrument system" that utilizes hardware components (chemiluminescent technology, pre-packaged reagent packs) in addition to software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The Trinidad Immunoassay (IM) system is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens." and "The Trinidad IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma..."
- Purpose: The device is designed to perform tests on clinical specimens (human serum and plasma) outside of the body to provide information for the diagnosis of thyroid or pituitary disorders. This is the core definition of an in vitro diagnostic device.
- Components: The description of the device and its components (reagents, calibrators) are consistent with those used in IVD assays.
N/A
Intended Use / Indications for Use
The Trinidad Immunoassay (IM) system is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. The Trinidad IM system's assay applications utilize chemiluminescent technology for clinical use.
The Trinidad IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the Trinidad IM system. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Trinidad IM TSH Calibrators are for in vitro diagnostic use in calibrating the Trinidad IM system TSH assay.
Product codes (comma separated list FDA assigned to the subject device)
JLW, JJE, JIT
Device Description
Trinidad Immunoassay (IM) System:
The Siemens Healthcare Diagnostics Trinidad Immunoassay (IM) system is a floor model, fully automated, microprocessor-controlled, integrated instrument system that utilizes chemiluminescent technology and uses pre-packaged reagent packs to measure a variety of analytes in human body fluids. It is controlled through a combination of custom and off-the-shelf software
The Trinidad IM system performs the following functions:
- Aspirates and dispenses samples
- Performs dilutions
- Adds reagents
- Incubates reaction vessels
- Separates solid and liquid wastes
- Measures photon emissions
- Performs data reduction
- Collects and maintains patient demographics and results
Trinidad IM TSH assay:
The Trinidad IM TSH assay reagent kit comes in two configurations (100 or 500 test kit) and each kit contains the following:
500 Test Kit:
- 5 ReadyPack primary reagent packs containing Trinidad IM TSH Lite Reagent, . Solid Phase, and Ancillary Reagent
- 2 vials of lyophilized Trinidad IM TSH low calibrator
- 2 vials of lyophilized Trinidad IM TSH high calibrator
100 Test Kit:
- 1 ReadyPack primary reagent packs containing Trinidad IM TSH Lite Reagent, . Solid Phase, and Ancillary Reagent
- 1 vial of lyophilized Trinidad IM TSH low calibrator
- 1 vial of lyophilized Trinidad IM TSH high calibrator
The ReadyPack consists of the following:
- Lite Reagent 6.0 mL/ reagent pack: ● The Lite Reagent contains bovine serum albumin (BSA) conjugated to murine monoclonal anti-TSH (~0.3 µg/mL) antibody labeled with acridinium ester, buffer, stabilizers (murine, bovine, caprine proteins), surfactant, and preservatives.
- Solid Phase Reagent 21.0 mL/ reagent pack: The Solid Phase reagent contains anti-fluorescein murine monoclonal antibody covalently linked to paramagnetic particles (~85 µg/mL), buffer, stabilizers (bovine, caprine proteins), surfactant, and preservatives.
- Ancillary Reagent 6.0 mL/ reagent pack: The Ancillary reagent contains FITC conjugated to murine monoclonal anti-TSH antibody (~3 µg/mL), buffer, stabilizers (murine, bovine, caprine proteins), surfactant, and preservatives.
The TSH Calibrator consists of the following:
- After reconstitution, low and high levels of thyroid stimulating hormone (TSH) in ● HEPES buffered equine serum with sodium azide ( 21 years) populations.
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)
Substantial equivalence of the Trinidad IM TSH assay on the Trinidad IM system was demonstrated by testing several performance characteristics including detection limits (LoB, LoD, and LoQ), imprecision, linearity, interfering substances and method comparison.
Detection Limits
The limit of blank (LoB), limit of detection (LoD), and the limit of quantitation (LoQ) of the Trinidad IM TSH assay were determined as described in CLSI Document EP17-A2. The Trinidad IM TSH assay had a LoB of 0.001 µIU/mL, a LoD of 0.005 µIU/mL, and a LoQ of 0.008 µIU/mL.
- The LoB was determined by assaying the TSH zero standard 10 times in each of at least 10 runs using 1 lot of reagent on 2 systems over a period of at least 5 days (n = 200).
- The LoD was determined by using low level TSH serum samples assayed in duplicate in each of at least 20 runs using 1 lot of reagents on 2 systems over a period of at least 10 days (n=80).
- The LoQ was determined by assaying multiple patient samples with low TSH values in duplicate in each of 10 runs on 2 systems over a period of 10 days.
Linearity
The Trinidad IM TSH analytical linearity was evaluated by testing a linearity pool that was prepared using a high TSH serum sample mixed with an equine serum pool to prepare nine (9) equally spaced pools, ranging in TSH levels from 0.0001 to 151 ulU/mL.
Key Result: The Trinidad IM TSH assay is linear from 0.0001 to 150 µIU/mL. The weighted linear regression of the Observed (y) vs. Expected (x) values for this pool is: y = 0.957x + 0.0000, R = 1.000.
Precision
Precision estimates were computed according to CLSI Document EP05-A2. Repeatability and within lab imprecision were evaluated by testing four commercial control, six serum samples and six plasma samples. Each sample was assayed in 2 replicates per run, 2 runs per day for 20 days for a total of 80 replicates. Testing was done using two reagent lots on two systems.
Interfering Substances
Interfering substances were tested as described in CLSI Document EP7-A2 using the Trinidad IM TSH assay.
Key Result: No indication of interference ( 21 years) populations.
Sample sizes: Infants (46), Children (136), Adolescents (160), Adults (155).
Expected values: Infants (0.87 - 6.15 µIU/mL), Children (0.67 - 4.16 µIU/mL), Adolescents (0.48-4.17 µIU/mL), Adults (0.55 - 4.78 µIU/mL).
Stability
The Trinidad IM TSH reagents are the same reagents as the Predicate ADVIA Centaur TSH3 Ultra reagents cleared in 510(k) K150403.
Key Result: The shelf-life stability of the Trinidad IM TSH reagents is identical to those of the ADVIA Centaur TSH3 Ultra reagents, which is 12 months at 2 – 8°C.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Detection Limits:
- LoB: 0.001 µIU/mL
- LoD: 0.005 µIU/mL
- LoQ: 0.008 µIU/mL
Linearity:
- y = 0.957x + 0.0000, R = 1.000
- Linear from 0.0001 to 150 µIU/mL
Precision (Within-Lab CV%):
- Control 1: 4.45 %
- Control 2: 4.20 %
- Control 3: 4.44 %
- Control 4: 4.95 %
- Plasma Pool 1: 4.51 %
- Plasma Pool 2: 5.95 %
- Plasma Pool 3: 5.34 %
- Plasma Pool 4: 4.00 %
- Plasma Pool 5: 4.19 %
- Plasma Pool 6: 4.82 %
- Serum Pool 1: 3.67 %
- Serum Pool 2: 4.15 %
- Serum Pool 3: 3.71 %
- Serum Pool 4: 3.59 %
- Serum Pool 5: 3.78 %
- Serum Pool 6: 4.72 %
Interference:
- Hemolyzed: ≤ 5% change up to 500 mg/dL of hemoglobin
- Lipemic: ≤ 5% change up to 1000 mg/dL of triglycerides
- Icteric: ≤ 5% change up to 40 mg/dL of conjugated bilirubin
- Icteric: ≤ 5% change up to 40 mg/dL of unconjugated bilirubin
High Dose Hook Effect:
- No high dose hook effect observed up to 3,000 µIU/mL.
Method Comparison:
- Slope: 1.07
- Intercept: -0.003
- R: 0.994
Serum Plasma Matrix Equivalency:
- Lithium Heparin Plasma vs Serum: Slope = 1.01, Intercept = -0.001, R = 1.00
- EDTA Plasma vs Serum: Slope = 1.00, Intercept = -0.000, R = 1.00
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
§ 862.1690 Thyroid stimulating hormone test system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and form a single, flowing shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2015
SIEMENS HEALTHCARE DIAGNOSTICS.INC. PHILIP LIU SENIOR MANAGER, REGULATORY AFFAIRS AND COMPLIANCE 511 BENEDICT AVENUE TARRYTOWN NY 10591
Re: K151792
Trade/Device Name: Trinidad IM Thyroid Stimulating Hormone (TSH) assay, Trinidad Immunoassay (IM) system, Trinidad IM TSH Calibrators Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: II Product Code: JLW, JJE, JIT Dated: October 15, 2015 Received: October 16, 2015
Dear Philip Liu:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K151792 |
| Device Name | Trinidad Immunoassay (IM) system |
| Trinidad IM Thyroid Stimulating Hormone (TSH) assay | |
| Trinidad IM TSH Calibrators | |
| Indications for Use (Describe) | The Trinidad Immunoassay (IM) system is an automated, immunoassay analyzer designed to perform in vitro diagnostic |
| tests on clinical specimens. The Trinidad IM system's assay applications utilize chemiluminescent technology for clinical | |
| use. |
The Trinidad IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the quantitative determination
of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the
Trinidad IM system. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the
diagnosis of thyroid or pituitary disorders.
The Trinidad IM TSH Calibrators are for in vitro diagnostic use in calibrating the Trinidad IM system TSH assay. |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
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information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
3
510(k) Summary of Safety and Effectiveness for the
Trinidad Immunoassay (IM) System Trinidad IM Thyroid Stimulating Hormone Assay
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. 510(k) Number:
B. Date of Preparation: November 18, 2015
C. Proprietary and Established Names:
Trinidad IM Thyroid Stimulating Hormone (TSH) Assay Trinidad IM TSH Calibrators Trinidad Immunoassay (IM) System
D. Applicant:
Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591 Philip Liu, Senior Manager, Requlatory Affairs and Compliance Office: (914) 524-2443 Fax: (914) 524-3579
E. Regulatory Information:
System
-
- Requlation section: 21 CFR § 862.2160
-
- Classification: Class I
-
- Product Code: JJE, Photometric Analyzer for Clinical Use
-
- Panel: Clinical Chemistry
Assay
-
- Regulation section: 21 CFR § 862.1690
-
- Classification: Class II
-
- Product Code: JLW, Thyroid stimulating hormone test system
-
- Panel: Clinical Chemistry
Calibrator
-
- Regulation section: 21 CFR § 862.1150
-
- Classification: Class II
-
- Product Code: JIT Calibrator, Secondary
-
- Panel: Clinical Chemistry
F. Predicate Devices:
ADVIA® Centaur XP system cleared under 510(k) K041133.
ADVIA® Centaur Thyroid Stimulating Hormone (TSH3 Ultra) Assay and Calibrators cleared under K150403.
4
G. Device Description:
Trinidad Immunoassay (IM) System:
The Siemens Healthcare Diagnostics Trinidad Immunoassay (IM) system is a floor model, fully automated, microprocessor-controlled, integrated instrument system that utilizes chemiluminescent technology and uses pre-packaged reagent packs to measure a variety of analytes in human body fluids. It is controlled through a combination of custom and off-the-shelf software
The Trinidad IM system performs the following functions:
- . Aspirates and dispenses samples
- . Performs dilutions
- . Adds reagents
- . Incubates reaction vessels
- . Separates solid and liquid wastes
- . Measures photon emissions
- . Performs data reduction
- . Collects and maintains patient demographics and results
Trinidad IM TSH assay:
The Trinidad IM TSH assay reagent kit comes in two configurations (100 or 500 test kit) and each kit contains the following:
500 Test Kit:
- 5 ReadyPack primary reagent packs containing Trinidad IM TSH Lite Reagent, . Solid Phase, and Ancillary Reagent
- . 2 vials of lyophilized Trinidad IM TSH low calibrator
- . 2 vials of lyophilized Trinidad IM TSH high calibrator
100 Test Kit:
- 1 ReadyPack primary reagent packs containing Trinidad IM TSH Lite Reagent, . Solid Phase, and Ancillary Reagent
- . 1 vial of lyophilized Trinidad IM TSH low calibrator
- . 1 vial of lyophilized Trinidad IM TSH high calibrator
The ReadyPack consists of the following:
- Lite Reagent 6.0 mL/ reagent pack: ● The Lite Reagent contains bovine serum albumin (BSA) conjugated to murine monoclonal anti-TSH (~0.3 µg/mL) antibody labeled with acridinium ester, buffer, stabilizers (murine, bovine, caprine proteins), surfactant, and preservatives.
- . Solid Phase Reagent 21.0 mL/ reagent pack: The Solid Phase reagent contains anti-fluorescein murine monoclonal antibody covalently linked to paramagnetic particles (~85 µg/mL), buffer, stabilizers (bovine, caprine proteins), surfactant, and preservatives.
- . Ancillary Reagent 6.0 mL/ reagent pack: The Ancillary reagent contains FITC conjugated to murine monoclonal anti-TSH antibody (~3 µg/mL), buffer, stabilizers (murine, bovine, caprine proteins), surfactant, and preservatives.
5
The TSH Calibrator consists of the following:
- After reconstitution, low and high levels of thyroid stimulating hormone (TSH) in ● HEPES buffered equine serum with sodium azide (in vitro diagnostic use in
calibrating TSH assay | Same |
| Antigen used in
calibrators | Thyroid stimulating hormone | Same |
| Number of levels | 2 | Same |
| Matrix | Lyophilized buffered equine serum | Same |
| Storage
temperature | 2-8°C | Same |
| Standardization /
Traceability | Standardized to internal standards and
is traceable to the World Health
Organization (WHO) 3rd International
standard for human TSH (IRP 81/565) | Same |
| Packaging | Provided with reagent kit | Same |
9
Calibrators:
Similarities and Differences:
K. Standard/Guidance Document Referenced (if applicable):
- CLSI Guideline EP05-A3: Evaluation of Precision Performance of Qualitative о Measurement Methods
- CLSI Guideline EP17-A2: Evaluation of Detection Capability for Clinical O Laboratory Measurement Procedures
- CLSI Guideline EP28-A3: Defining, Establishing, And Verifying Reference O Intervals In The Clinical Laboratory; Approved Guideline- Third Edition
- CLSI Guideline EP7-A2: Interference Testing in Clinical Chemistry; Approved O Guideline
L. Test Principle
The Trinidad IM TSH assay is a third-generation assay that employs anti-FITC monoclonal antibody covalently bound to paramagnetic particles, an FITC-labeled anti-TSH capture monoclonal antibody, and a tracer consisting of a proprietary acridinium ester and an anti-TSH monoclonal antibody conjugated to bovine serum albumin (BSA) for chemiluminescent detection. A direct relationship exists between the amount of TSH present in the patient sample and the amount of relative light units (RLUs) detected by the system.
M. Performance Characteristics
Substantial equivalence of the Trinidad IM TSH assay on the Trinidad IM system was demonstrated by testing several performance characteristics including detection limits (LoB, LoD, and LoQ), imprecision, linearity, interfering substances and method comparison.
10
a. Detection Limits
The limit of blank (LoB), limit of detection (LoD), and the limit of quantitation (LoQ) of the Trinidad IM TSH assay were determined as described in CLSI Document EP17-A2. The Trinidad IM TSH assay had a LoB of 0.001 µIU/mL, a LoD of 0.005 µIU/mL, and a LoQ of 0.008 µIU/mL.
The LoB is defined as the concentration of TSH that corresponds to the 95th percentile of the distribution of the TSH zero standard; the TSH zero standard was assayed 10 times in each of at least 10 runs using 1 lot of reagent on 2 systems over a period of at least 5 days (n = 200).
The LoD is defined as the lowest concentration of TSH that can be detected with 95% probability. The LoD was determined by using low level TSH serum samples that were assayed in duplicate in each of at least 20 runs using 1 lot of reagents on 2 systems over a period of at least 10 days (n=80).
The LoQ, or functional sensitivity, is the lowest concentration of TSH at which the total imprecision for the assay does not exceed 20%, and was determined by assaying multiple patient samples with low TSH values in duplicate in each of 10 runs on 2 systems over a period of 10 days.
b. Linearity
The Trinidad IM TSH analytical linearity was evaluated by testing a linearity pool that was prepared using a high TSH serum sample mixed with an equine serum pool to prepare nine (9) equally spaced pools, ranging in TSH levels from 0.0001 to 151 ulU/mL. The weighted linear regression of the Observed (y) vs. Expected (x) values for this pool is:
y = 0.957x + 0.0000, R = 1.000
The Trinidad IM TSH assay is linear from 0.0001 to 150 µIU/mL.
c. Precision
Precision estimates were computed according to CLSI Document EP05-A2, Evaluation of Precision Performance of Quantitative Measurement Methods: Approved Guideline. Repeatability and within lab imprecision were evaluated by testing four commercial control, six serum samples and six plasma samples. Each sample was assayed in 2 replicates per run, 2 runs per day for 20 days for a total of 80 replicates. Testing was done using two reagent lots on two systems.
A representative lot is summarized below:
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| Repeatability | Within-Lab | |||||
|---|---|---|---|---|---|---|
| Specimen Type | N | Mean | ||||
| (µIU/mL) | SD | |||||
| (µIU/mL) | CV | |||||
| (%) | SD | |||||
| (µIU/mL) | CV | |||||
| (%) | ||||||
| Control 1 | 80 | 0.034 | 0.00 | 2.36 | 0.00 | 4.45 |
| Control 2 | 80 | 0.40 | 0.01 | 1.96 | 0.02 | 4.20 |
| Control 3 | 80 | 5.26 | 0.09 | 1.74 | 0.23 | 4.44 |
| Control 4 | 80 | 32.8 | 0.60 | 1.82 | 1.62 | 4.95 |
| Plasma Pool 1 | 80 | 3.38 | 0.08 | 2.34 | 0.15 | 4.51 |
| Plasma Pool 2 | 80 | 37.9 | 1.26 | 3.32 | 2.25 | 5.95 |
| Plasma Pool 3 | 80 | 144 | 3.68 | 2.56 | 7.67 | 5.34 |
| Plasma Pool 4 | 80 | 0.72 | 0.01 | 1.45 | 0.03 | 4.00 |
| Plasma Pool 5 | 80 | 4.99 | 0.11 | 2.12 | 0.21 | 4.19 |
| Plasma Pool 6 | 80 | 79.9 | 1.79 | 2.24 | 3.86 | 4.82 |
| Serum Pool 1 | 80 | 1.11 | 0.02 | 1.46 | 0.04 | 3.67 |
| Serum Pool 2 | 80 | 5.83 | 0.09 | 1.47 | 0.24 | 4.15 |
| Serum Pool 3 | 80 | 11.4 | 0.21 | 1.86 | 0.42 | 3.71 |
| Serum Pool 4 | 80 | 34.7 | 0.63 | 1.80 | 1.25 | 3.59 |
| Serum Pool 5 | 80 | 59.9 | 1.06 | 1.76 | 2.27 | 3.78 |
| Serum Pool 6 | 80 | 132 | 2.66 | 2.01 | 6.23 | 4.72 |
d. Interfering Substances
Interfering substances were tested as described in CLSI Document EP7-A2 using the Trinidad IM TSH assay. There was no indication of interference ( 21 years) populations. The number of individuals tested and used in the analysis and the Expected Values are as follows:
| Age Range | N | Expected Values |
|---|---|---|
| Infants (01 - 23 months) | 46 | 0.87 - 6.15 µIU/mL |
| Children (02 - 12 years) | 136 | 0.67 - 4.16 µIU/mL |
| Adolescents (13 - 20 years) | 160 | 0.48-4.17 µIU/mL |
| Adults (≥ 21 years) | 155 | 0.55 - 4.78 µIU/mL |
k. Stability
The Trinidad IM TSH reagents are the same reagents as the Predicate ADVIA Centaur TSH3 Ultra reagents cleared in 510(k) K150403. The packaging is identical and the only difference is the labeling. Therefore, the shelf-life stability of the Trinidad IM TSH
13
reagents is identical to those of the ADVIA Centaur TSH3 Ultra reagents. The shelf-life stability of the reagents was provided in 510(k) K150403 as 12 months at 2 – 8°C.
N. Conclusions
Comparative testing of the Trinidad IM TSH assay on the Trinidad IM system is substantially equivalent in principle and performance to the Predicate Device ADVIA Centaur TSH3 Ultra assay on the ADVIA Centaur system cleared under 510(k) K150403.