(130 days)
K0003668
Not Found
No
The device description details a standard immunoassay technique based on antibody binding and fluorescence measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is a diagnostic tool used for screening newborns for cystic fibrosis by measuring IRT levels, not for treating or preventing a disease or condition.
Yes
The device is intended for the quantitative determination of immunoreactive trypsin(ogen) (IRT) in blood specimens "as an aid in screening newborns for cystic fibrosis." This indicates that it provides information used to diagnose or screen for a disease.
No
The device description clearly outlines a "solid phase, two-site fluoroimmunometric assay" involving antibodies, assay buffer, and fluorescence measurement, indicating a chemical and hardware-based laboratory test 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 human immunoreactive trypsin(ogen) (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis." This involves testing a sample taken from the body (blood) in vitro (outside the body) to provide information about a medical condition (cystic fibrosis screening).
- Device Description: The description details a "solid phase, two-site fluoroimmunometric assay" which is a laboratory test method performed on biological samples.
- Sample Type: The device uses "blood specimens dried on filter paper," which are biological samples.
- Testing Location: The intended user is "adequately trained laboratory personnel in laboratories performing newborn screening," indicating the testing is done in a laboratory setting, not directly on the patient.
All these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AutoDELFIA Neonatal IRT kit is intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA® automatic immunoassay system.
Product codes
JNO
Device Description
The AutoDELFIA 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 and 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 the dried blood on filter paper disks. The complete assay requires only one incubation step.
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)
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
JUN 1 0 2011
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: January 26, 2010
Submitted by:
Wallac Oy, subsidiary of PerkinElmer 940 Winter Street Waltham, MA 02451 USA
Contact Person: Primary:
Susan K. Hamann Tel: 781-663-5872 Fax: 781-663-5983
Kay A. Taylor
JNO
Tel: 317-418-1735 Fax: 317-536-3064
Secondary:
Trade Name:
Common Name: Regulation:
AutoDELFIA Neonatal IRT kit 21 CFR 862.1725
Trypsin Test System and Electrode
Classification Name:
Product Code:
Predicate Device:
Device Description:
AutoDELFIA® Neonatal IRT kit, B005-112
AutoDELFIA® Neonatal IRT kit B005-212, B005-204
510(k) Number (K0003668)
The AutoDELFIA 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 and 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 the dried blood on filter paper disks. The complete assay requires only one incubation step.
1
Enhancement Solution dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of the Enhancement Solution. The fluorescence in each well is then measured. The fluorescence of each sample is proportional to the concentration of IRT in the sample.
The AutoDELFIA Neonatal IRT kit is intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA® automatic immunoassay system.
Substantial Equivalence: The AutoDELFIA Neonatal IRT kit (B005-212/B005-204) is substantially equivalent to the currently marketed AutoDELFIA IRT kit (B005-112) (K0003668). There are the following similarities and differences between the two kits:
Intended Use:
2
Table 1. Characteristics of the two kits.
・.
| Characteristic (Feature) | AutoDELFIA Neonatal
IRT kit
B005-212/B005-204
(New Device) | AutoDELFIA Neonatal
IRT kit
B005-112
(Predicate Device) |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended User | Adequately trained laboratory
personnel in laboratories
performing newborn
screening | Same |
| Intended Use / Indications for Use | The AutoDELFIA Neonatal
IRT kit (B005-212/B005-204)
is intended for the quantitative
determination of human
immunoreactive trypsin(ogen)
(IRT) in blood specimens
dried on filter paper as an aid
in screening newborns for
cystic fibrosis using the 1235
AutoDELFIA® automatic
immunoassay system. | The AutoDELFIA Neonatal
IRT (B005-112) is intended
for the quantitative
determination of human
immunoreactive trypsin (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 AutoDELFIA 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. | Same |
| Characteristic (Feature) | AutoDELFIA Neonatal
IRT kit
B005-212/B005-204
(New Device) | AutoDELFIA Neonatal
IRT kit
B005-112
(Predicate Device) |
| | from the labeled antibody into solution where they form
highly fluorescent chelates with components of the
Enhancement Solution. 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
(Whatman, no. 903) | Same |
| | (Washed blood cells in buffer
containing BSA and protease
inhibitors)
(Filter paper on a supportive
frame called "cassette") | (Washed blood cells in saline
containing saccharose)
(Filter paper as sheets) |
| Kit Calibrators | 6 levels.
(approx. values 0, 25, 50, 100,
250, 500 ng/mL blood. | Same |
| Kit Controls | 3 levels (approx. values 30, 70
and. 110 ng/mL blood) | 3 levels (approx. values 40,
70 and 120 ng/mL blood) |
| Calibration | Calibrated using gravimetric
methods | Same |
| | (In-house calibrators contain
protease inhibitors and BSA
item 1.) | (In-house calibrators without
protease inhibitors, contain
BSA item 2.) |
| Assay buffer | IRT Assay Buffer, ready for
use
Tris-HCl buffered (pH 7.8)
salt solution with bovine
serum albumin, and additives. | Same |
| Characteristic (Feature) | AutoDELFIA Neonatal
IRT kit
B005-212/B005-204
(New Device)
(BSA item 1 used) | AutoDELFIA Neonatal
IRT kit
B005-112
(Predicate Device)
(BSA item 2 used) |
| 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 |
| Tracer | Anti-IRT-Eu tracer stock
solution (~50 µg/mL), mouse
monoclonal, ready for use. . | Same |
| Instrument | 1235 AutoDELFIA Instrument | Same |
| Dissociation solution | Enhancement Solution | 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
IRT cut-off levels must be
determined by each newborn
screening laboratory to meet
the desired sensitivity and
specificity of the screen and
should be evaluated
periodically. | Same |
| Measuring Range | 16 to 480 ng/mL blood
Linearity Range: 16 to 480
ng/mL blood | 4(as defined by LoB) to 500 (as
defined by upper calibrator)
ng/mL blood
Linearity Range: No claims for
linearity in labeling. |
| Analytical Sensitivity / Limit of
Blank, | Limit of Blank
0.53 ng/mL blood | Limit of Blank