(147 days)
Not Found
No
The description details a standard immunoassay technique and does not mention any AI or ML components.
No
This device is for in vitro diagnostic (IVD) use, specifically for screening newborns for congenital hypothyroidism by measuring T4 levels. It does not provide any therapeutic intervention.
Yes
The device is intended for the quantitative determination of human thyroxine (T4) in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism, which is a diagnostic purpose.
No
The device description clearly outlines a laboratory assay kit involving chemical reactions, antibodies, and fluorescence measurement, which are hardware components and processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of human thyroxine (T4) in blood specimens dried on filter paper." This involves testing a biological sample (blood) in vitro (outside the body).
- Device Description: The description details a "solid phase time-resolved fluoroimmunoassay," which is a laboratory technique performed in vitro to measure substances in biological samples.
- Sample Type: The device uses "blood specimens dried on filter paper," which are biological samples collected from the patient for in vitro analysis.
- Intended User/Care Setting: The intended users are "adequately trained laboratory personnel in laboratories performing newborn screening," indicating a laboratory setting where in vitro testing is conducted.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The GSP Neonatal IRT kit is intended for the quantitative determination of human thyroxine (T4) in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism using the GSP® instrument.
The GSP Neonatal Thyroxine (T4) kit is intended for the quantitative determination of human thyroxine (T4) in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism using the GSP instrument.
Product codes (comma separated list FDA assigned to the subject device)
KLI
Device Description
The GSP Neonatal T4 assay is a solid phase time-resolved fluoroimmunoassay based on the competitive reaction between europium-labeled T4 and sample T4 for a limited amount of binding sites on T4 specific monoclonal antibodies (derived from mice). The use of 8-anilino-1-naphthalenesulfonic acid (ANS) and salicylate in the T4 Assay Buffer facilitates the release of T4 from the binding proteins. Thus the assay measures the total amount of T4 in the test specimen. A second antibody, directed against mouse IgG, is coated to the solid phase, and binds the IgG-thyroxine complex, giving convenient separation of the antibodybound and free antigen. DELFIA Inducer dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the concentration of T4 in the sample.
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
newborns
Intended User / Care Setting
Adequately trained laboratory personnel in laboratories performing newborn screening.
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
§ 862.1700 Total thyroxine test system.
(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(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
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.
The Assigned 510(k) Number is:
Date: April 12, 2011
Submitted by:
Wallac Oy, subsidiary of PerkinElmer 940 Winter Street Waltham, MA 02451 USA
Contact Person: Susan K. Hamann Primary: Tel: 781-663-5872 Fax: 781-663-5983
Secondary:
Kay A. Taylor Tel: 317-418-1735 Fax: 317-536-3064
Trade Name:
Common Name: GSP Neonatal Thyroxine (T4) kit
Regulation: 21 CFR 862.1700
Classification Name: Total Thyroxine Test System
Product Code:
AutoDELFIA® Neonatal Thyroxine T4 Predicate Device: 510(k) Number (K943416)
KLI
Device Description: The GSP Neonatal T4 assay is a solid phase time-resolved fluoroimmunoassay based on the competitive reaction between europium-labeled T4 and sample T4 for a limited amount of binding sites on T4 specific monoclonal antibodies (derived from mice). The use of 8-anilino-1-naphthalenesulfonic acid (ANS) and salicylate in the T4 Assay Buffer facilitates the release of T4 from the binding proteins. Thus the assay measures the total amount of T4 in the test specimen. A second antibody, directed against mouse IgG, is coated to the solid phase, and binds the IgG-thyroxine complex, giving convenient separation of the antibodybound and free antigen.
GSP® Neonatal Thyroxine (T4) kit (3302-001U)
DELFIA Inducer dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of DELFIA Inducer.
1
The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the concentration of T4 in the sample.
Intended Use:
The GSP Neonatal IRT kit is intended for the quantitative determination of human thyroxine (T4) in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism using the GSP® instrument.
Substantial Equivalence:
The GSP® Neonatal Thyroxine (T4) kit is substantially equivalent to our currently marketed AutoDELFIA® Neonatal Thyroxine T4 (K943416). There are the following similarities and differences between the two kits:
2
| Predicate
| Device | FEATURE | Similarities (AutoDELFIA T4) | Differences (GSP T4) |
|---|---|---|---|
| AutoDELFIA | |||
| Neonatal T4 Kit | Intended User | Adequately trained laboratory personnel in | |
| laboratories performing newborn screening. | Same | ||
| AutoDELFIA | |||
| Neonatal T4 Kit | Intended use | This kit is intended for the quantitative | |
| determination of human thyroxine (T4) in | |||
| blood specimens dried on filter paper as an | |||
| aid in screening newborns for congential | |||
| (neonatal) hypothyroidism using the | |||
| AutoDELFIA automatic immunoassay | |||
| system. | The kit is intended for the quantitative | ||
| determination of human thyroxine (T4) in blood | |||
| specimens dried on filter paper as an aid in | |||
| screening newborns for congenital (neonatal) | |||
| hypothyroidism using the GSP instrument. | |||
| AutoDELFIA | |||
| Neonatal T4 Kit | Chemical | ||
| Principle | The Neonatal T4 assay is a solid phase | ||
| time-resolved fluoroimmunoassay based on | |||
| the competitive reaction between europium- | |||
| labeled T4 and sample T4 for a limited | |||
| amount of binding sites on T4 specific | |||
| monoclonal antibodies (derived from mice). | |||
| The use of 8-anilino-1-naphthalenesulfonic | |||
| acid (ANS) and salicylate in the T4 Assay | |||
| Buffer facilitates the release of T4 from the | |||
| binding proteins. Thus the assay measures | |||
| the total amount of T4 in the test specimen. | |||
| A second antibody, directed against mouse | |||
| IgG, is coated to the solid phase, and binds | |||
| the IgG-thyroxine complex, giving | |||
| convenient separation of the antibody-bound | |||
| and free antigen. | Same | ||
| AutoDELFIA | |||
| Neonatal T4 Kit | Chemical | ||
| Principle | Europium ions are dissociated from the | ||
| labeled antibody into solution where they | |||
| form highly fluorescent chelates with | |||
| components of the dissociation solution. |
The fluorescence in each well is then
measured. The fluorescence of each sample
is inversely proportional to the concentration
of T4 in the sample | Same |
| AutoDELFIA
Neonatal T4 Kit | Dissociation
Solution | Enhancement Solution. | DELFIA Inducer |
| AutoDELFIA
Neonatal T4 Kit | Detection
Principle | Time-resolved fluorescence | Same |
| AutoDELFIA
Neonatal T4 Kit | Specimen | Dried blood on filter paper disks with a
diameter of approximately 3.2 mm (1/8 inch) | Same |
| AutoDELFIA
Neonatal T4 Kit | Antibodies | Primary mouse monoclonal antibody and | Same |
| | FEATURE | Similarities (AutoDELFIA T4) | Differences (GSP T4) |
| DELFIA
Neonatal T4 Kit | Calibrators | Six levels of T4 calibrators | Same |
| DELFIA
Neonatal T4 Kit | Source | Human blood with a hematocrit value of 50-55% | Same |
| DELFIA
Neonatal T4 Kit | Matrix | Filter paper sheets
(Whatman no. 903) | Filter paper cassettes (Whatman no.903) |
| DELFIA
Neonatal T4 Kit | Calibrator
Concentrations | A 0 µg/dL serum
B 2 µg/dL serum
C 4 µg/dL serum
D 8 µg/dL serum
E 16 µg/dL serum
F 30 µg/dL serum | Same |
| DELFIA
Neonatal T4 Kit | Controls | Three levels of T4 controls | Same |
| DELFIA
Neonatal T4 Kit | Control
Concentrations | Approx. values:
C1 3 µg/dL serum
C2 7 µg/dL serum
C3 12 µg/dL serum | Same |
| DELFIA
Neonatal T4 Kit | Tracer | T4-Eu (~25 nmol/L);
6 vials, lyophilized | T4-Eu (~10 nmol/L);
3 vials, 2.8 mL |
| DELFIA
Neonatal T4 Kit | Antibody | T4 antibody stock solution (~40 nmol/L);
6 vials, 1.5 mL | T4 antibody (~12 nmol/L);
3 vials, 2.8 mL |
| DELFIA
Neonatal T4 Kit | Assay Buffer | T4 Assay Buffer
3 bottles, 110 mL | Same |
| DELFIA
Neonatal T4 Kit | Plates | Anti-Mouse IgG Microtitration strips (Nunc
PolySorb); 12 plates | Anti-Mouse IgG Microtitration strips (Nunc
MaxiSorb); 12 plates |
| DELFIA
Neonatal T4 Kit | Detection | Defined by analyte specific protocol | Same |
| DELFIA
Neonatal T4 Kit | Calculation | Multicalc, X- axis LOG, Y-axis B/BMax;
fitting algorithm spline smoothed | GSP Workstation software,
X-axis Hyberbolic,
Y-axis Bound2Max; fitting algorithm spline
smoothed |
| DELFIA
Neonatal T4 Kit | Incubation Detail | 11min + 2 hours, 25°C | 10 min + 2 hours, 25°C |
| DELFIA
Neonatal T4 Kit | Precision
(levels/CVs) | Full standard curve on each plate:
Control 1; 3.95 µg/dL serum
Intra-assay variation 14.9 %
Inter-assay variation 10.0 %
Total variation 18.0 % | Full calibration curve on each plate:
Sample 1; 2.0 µg/dL
Within run 1.0%
Within lot 15.5%
Total variation 15.8% |
| Predicate Device | FEATURE | Similarities (AutoDELFIA T4) | Differences (GSP T4) |
| | | Control 2; 8.08 µg/dL serum
Intra-assay variation 10.6 %
Inter-assay variation 7.1 %
Total variation 12.7 % | Sample 2; 4.8 µg/dL
Within run 7.3%
Within lot 10.7%
Total variation 11.4% |
| | | Control 3; 18.2 µg/dL serum
Intra-assay variation 8.2%
Inter-assay variation 4.3%
Total variation 9.3 % | Sample 3; 7.5 µg/dL
Within run 6.5%
Within lot 8.4%
Total variation 8.6% |
| | | | Sample 4; 16.6 µg/dL
Within run 4.5%
Within lot 7.8%
Total variation 8.5% |
| | | | Sample 5; 19.8 µg/dL
Within run 7.2%
Within lot 9.9%
Total variation 10.3% |
| | | | Sample 6; 21.4 µg/dL
Within run 7.1%
Within lot 9.8%
Total variation 10.1% |
| AutoDELFIA
Neonatal T4 Kit | Measuring Range | 1.5 µg/dL to the highest level calibrator | 1.6 to 30 µg/dL serum |
| AutoDELFIA
Neonatal T4 Kit | Limit of Blank | Trade Name: GSP Neonatal Thyroxine (T4) kit Regulation Number: 21 CFR §862.1700 Regulation Name: Total thyroxine test system. Regulatory Class: Class II Product Code: KLI Dated: November 24, 2010 Received: February 24, 2011
Dear Ms. Hamann:
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).
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.C.
Courtney Harper, 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 Form
510(k) Number (if known): __K103484
Device Name: The GSP Neonatal Thyroxine (T4) kit (3302-001U)
Indications for Use:
The GSP Neonatal Thyroxine (T4) kit is intended for the quantitative determination of human thyroxine (T4) in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism using the GSP instrument.
Prescription Use ਮ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103484
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