AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT

K042425 · Wallac OY · JLX · Sep 30, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042425
• Device Name: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
• Applicant: Wallac OY
• Product Code: JLX · Clinical Chemistry
• Decision Date: Sep 30, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1395
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The AutoDELFIA Neonatal 17α-ΟΗ-progesterone kit is intended for the quantitative determination of 17α-OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the 1235 AutoDELFIA automatic immunoassay system.

Device Story

The AutoDELFIA Neonatal 17α-OH-progesterone kit is an in vitro diagnostic assay used in neonatal screening laboratories. It utilizes dried blood spot samples collected on filter paper. The assay is a solid-phase, time-resolved fluoroimmunoassay based on competitive binding: europium-labeled 17-OHP and sample 17-OHP compete for binding sites on rabbit-derived polyclonal antibodies. Danazol is used to release 17-OHP from binding proteins. A second antibody, directed against rabbit IgG, is coated to the solid phase to separate bound and free antigen. An enhancement solution dissociates europium ions into fluorescent chelates. The 1235 AutoDELFIA automatic immunoassay system measures the resulting fluorescence, which is inversely proportional to the 17-OHP concentration in the sample. Healthcare providers use these quantitative results to screen newborns for congenital adrenal hyperplasia, facilitating early clinical intervention.

Clinical Evidence

Performance was evaluated through in-house studies and studies conducted in neonatal screening laboratories. The modified kit demonstrated performance equivalent to the predicate AutoDELFIA Neonatal 17α-OH-progesterone kit.

Technological Characteristics

Solid-phase, time-resolved fluoroimmunoassay. Components: filter paper for blood collection, 6 standards, 3 controls, rabbit polyclonal antibody-based 17-OHP antiserum. Class I device (21 CFR 862.1395).

Indications for Use

Indicated for screening newborns for an acquired genetic disorder.

Regulatory Classification

Identification

A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.

Predicate Devices

• DELFIA / AutoDELFIA Neonatal 17 a-OH-progesterone kit (K912026)
• AutoDELFIA Neonatal 17 a-OH-progesterone kit (K935047)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE

Re: K 042425 Wallac Oy, AutoDELFIA® Neonatal 17α-OH- Pogesterone kit

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was to: Change raw material, and to summarize minor changes that have been made since the 1991/1995 submission. The following describes the modifications made:

Kit standards and controls in the first version of the assay have been changed to include a change in the filter paper used for the collection of newborn blood samples in the U.S.

The number of standards and controls has been changed from initially 7 standards and 2 controls to 6 standards and 3 controls.

The final modification is the change of the rabbit polyclonal antibody used in the 17-OHP antiserum.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, immunoassay technology, test protocol, performance, assay principle, cutoff level and reagents.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the

{1}

2

submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

This device is a class I as specified under regulation 21 CFR 862.1395. However, it is not exempt from a premarket submission since it meets the exemptions specified in 21 CFR 862.9(c)(2) because it is intended for screening newborns for an acquired genetic disorder.