(113 days)
K0003668
Not Found
No
The device description details a standard fluoroimmunometric assay based on chemical reactions and fluorescence measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is for in vitro diagnostic screening, not for therapy or treatment.
Yes
The device is described as an "aid in screening newborns for cystic fibrosis," which indicates its use in identifying a disease or condition. It determines the quantitative levels of IRT in blood specimens, which is a diagnostic measurement.
No
The device description clearly outlines a "solid phase, two-site fluoroimmunometric assay" involving antibodies, assay buffer, and a "GSP® instrument" for measurement. This indicates a hardware-based laboratory assay kit, not a software-only device.
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 IRT in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis." This involves testing a biological sample (blood) outside of the body (in vitro) to provide information for a medical purpose (screening for cystic fibrosis).
- Device Description: The description details a "solid phase, two-site fluoroimmunometric assay" which is a laboratory test performed on biological samples.
- Anatomical Site: The sample is "Blood specimens dried on filter paper," which is a biological specimen.
- Intended User / Care Setting: The intended users are "Adequately trained laboratory personnel in laboratories performing newborn screening," indicating a laboratory setting where in vitro tests are conducted.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GSP Neonatal IRT kit is intended for the quantitative determination of IRT in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the GSP® instrument.
The GSP Neonatal IRT kit is intended for the quantitative determination of human immunoreactive trypsin(ogen) in blood specimens dried on filter paper as an aid in screening newborns for Cystic Fibrosis using the GSP® instrument.
Product codes
JNO
Device Description
The GSP Neonatal IRT assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the IRT molecule. Calibrators, controls or test specimens containing IRT are reacted simultaneously with immobilized monoclonal antibodies directed against a specific antigenic site on the IRT molecule and europium-labeled monoclonal antibodies (directed against a different antigenic site) in assay buffer. The assay buffer elutes IRT from dried blood on filter paper disks. The complete assay requires only one incubation step. DELFIA Inducer dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of the DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is proportional to the concentration of IRT 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K0003668
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1725 Trypsin test system.
(a)
Identification. A trypsin test system is a device intended to measure the activity of trypsin (a pancreatic enzyme important in digestion for the breakdown of proteins) in blood and other body fluids and in feces. Measurements obtained by this device are used in the diagnosis and treatment of pancreatic disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
510(k) SUMMARY
- 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: K102419
Date: December 9, 2010
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 Kay A. Taylor Secondary: Tel: 317-418-1735 Fax: 317-536-3064 Trade Name: GSP® Neonatal IRT kit (3306-001U) Common Name: GSP Neonatal IRT kit Regulation: 21 CFR 862.1725 Classification Name: Trypsin Test System Product Code: JNO AutoDELFIA® Neonatal IRT kit, Predicate Device: 510(k) Number (K0003668) Device Description: The GSP Neonatal IRT assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the IRT molecule. Calibrators, controls or test specimens containing IRT are reacted simultaneously with immobilized monoclonal antibodies directed against a specific antigenic site on the IRT molecule and europium-labeled monoclonal antibodies (directed against a different antigenic site) in assay buffer. The assay buffer elutes IRT from dried blood on filter paper disks. The
complete assay requires only one incubation step.
l
1
DELFIA Inducer dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of the DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is proportional to the concentration of IRT in the sample.
Intended Use:
The GSP Neonatal IRT kit is intended for the quantitative determination of IRT in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the GSP® instrument.
.Substantial Equivalence:
The GSP Neonatal IRT kit is substantially equivalent to our currently marketed - AutoDELFIA - IRT kit (K0003668). There are the following similarities and differences between the two kits:
2
Table 1. Characteristics of the two kits.
| Characteristic | GSP Neonatal IRT kit
(New Device) | AutoDELFIA Neonatal IRT kit
(Predicate Device) | |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Similarities | | | |
| Intended User | Adequately trained laboratory personnel in laboratories performing newborn screening | Same | |
| Intended Use / Indications for Use | The GSP Neonatal IRT kit is intended for the quantitative determination of IRT in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the GSP® instrument. | The AutoDELFIA Neonatal IRT kit is intended for the quantitative determination of human IRT in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA automatic immunoassay system. | |
| Chemical Principle | The GSP Neonatal IRT assay is a solid phase, two-site fluorimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the IRT molecule. Calibrators, controls, or test specimens containing IRT are reacted simultaneously with immobilized monoclonal antibodies directed against a specific antigenic site on the IRT molecule and europium-labeled monoclonal antibodies (directed against a different antigenic site) in assay buffer. The assay buffer elutes IRT from dried blood on filter paper disks. The complete assay requires only one incubation step.
DELFIA Inducer dissociates europium ions from the | Same | |
| Characteristic | GSP Neonatal
IRT kit
(New Device) | AutoDELFIA Neonatal
IRT kit
(Predicate Device) | |
| | fluorescent chelates with
components of the DELFIA
Inducer. The fluorescence in
each well is then measured.
The fluorescence of each
sample is proportional to the
concentration of IRT in the
sample. | | |
| Detection principle | Time-resolved fluorescence | Same | |
| Specimen | Dried blood on filter paper
disks with a diameter of
approximately 3.2 mm (1/8
inch) | Same | |
| Antibodies | Two different mouse
monoclonal antibodies | Same | |
| Calibrator and Control Matrix | Human blood derivative with
a hematocrit of 50-55% and
spotted onto filter paper
cassettes (Whatman, no. 903) | Same | |
| | (Washed RBCs in buffer
containing BSA and protease
inhibitors) | (Washed RBCs in buffer
containing saccharose) | |
| Calibration | Calibrated using gravimetric
methods | Same | |
| Controls | 3 levels (approx. values 30, 70
and 110 ng/mL blood) | Same | |
| Assay buffer | IRT Assay Buffer, ready for
use | Same | |
| | Containing blockers and BSA
item 1 | Containing BSA item 2 | |
| Calibrators | 6 levels
(approx. values 0, 25, 50, 100,
250, 500 ng/mL blood) | Same | |
| Expected Values | The measurement of IRT
from dried blood spots is used
as a means of identifying a
population of newborns who
are at increased risk of having
CF and should be selected for
2nd tier testing. The
identification is based on the
use of a fixed cut-off value or
population percentile. The | Same | |
| Characteristic | GSP Neonatal
IRT kit | AutoDELFIA Neonatal
IRT kit | |
| | (New Device) | (Predicate Device) | |
| | determined by each newborn
screening laboratory to meet
the desired sensitivity and
specificity of the screen and
should be evaluated
periodically. | | |
| Coated Plates | Anti-IRT Microtitration
Strips, 8 X 12 wells coated
with antibodies directed
against a specific site on the
IRT molecule (mouse
monoclonal) | Same | |
| | Microtitration plate raw
material item 1. | Microtitration plate raw
material item 2 | |
| Characteristic | GSP Neonatal
IRT kit
(New Device) | Differences | AutoDELFIA Neonatal
IRT kit
(Predicate Device) |
| Instrument | GSP Instrument | | 1235 AutoDELFIA Instrument |
| Dissociation solution | DELFIA Inducer | | Enhancement Solution |
| Antibody
Cross-Reactions
in the Assay | α2-macroglobulin | 0.000% | α2-macroglobulin