MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT

K050960 · Wallac OY · JLX · Jul 11, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050960
• Device Name: MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
• Applicant: Wallac OY
• Product Code: JLX · Clinical Chemistry
• Decision Date: Jul 11, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1395
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The AutoDELFIA Neonatal 17α-OH-progesterone L kit is intended for the quantitative determination of 17a-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

AutoDELFIA Neonatal 17α-OH-progesterone kit is an immunoassay system for neonatal screening. Modification involves changing calibrators and controls from dried blood spots to a TRIS-HCL salt solution with BSA. Device utilizes immunoassay technology to measure 17α-OH-progesterone levels. Used in clinical laboratory settings by trained personnel. Output provides quantitative hormone concentration data to assist in neonatal endocrine screening. Modification maintains fundamental scientific technology of the previously cleared device.

Clinical Evidence

Bench testing only; performance of the modified kit was validated against the original predicate device.

Technological Characteristics

Solid-phase, time-resolved fluoroimmunoassay. Components: europium-labeled 17-OHP, rabbit-derived polyclonal antibodies, Danazol, second antibody (anti-rabbit IgG) coated solid phase, Enhancement Solution. Measurement: fluorescence intensity. System: 1235 AutoDELFIA automatic immunoassay system.

Indications for Use

Indicated for the quantitative determination of 17α-OH-progesterone in neonatal blood samples.

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

• AutoDELFIA® Neonatal 17 α-OH-progesterone kit (K042425)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum

To: THE FILE

Pogesterone kit

Re: k 050960 Wallac Oy, AutoDELFINA® Neonatal 17α-OH-

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: Request a modification to the AutoDELFIA Neonatal 17 α-OH-progesterone kit. According to this modification, calibrators and controls in TRIS-HCL salt solution with BSA will be used instead of dried blood spots.

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 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 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.

Reviewer Comments:

The modification to this device was to modify the calibrators and controls. The calibrators and controls are now in TRIS-HCL salt solution with BSA; instead of dried blood spots utilized in the previous submission. In addition, the submitter's description of the particular modification(s) and

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the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed.

## Regulatory Classification

Radioimmunoassay, 17 Hydroxyprogesterone
862.1395
JLX
I
Panel 75