VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS

K032296 · Ortho-Clinical Diagnostics, Inc. · JIS · Aug 13, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032296
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JIS · Clinical Chemistry
• Decision Date: Aug 13, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

VITROS Progesterone Reagent Pack For in vitro diagnostic use only. The Vitros Progesterone Reagent Pack quantitatively measures progesterone concentration in human serum and plasma. VITROS Progesterone Calibrators For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of progesterone in human serum and plasma (EDTA or heparin).

Device Story

The VITROS Progesterone assay is a solid-phase immunoassay used for the quantitative determination of progesterone in human serum and plasma. The system utilizes coated microwells as a solid-phase separation system and enzyme-labeled tracers to generate a luminescent signal. The device is operated on the VITROS Immunodiagnostic System, which automates the immunoassay process. The system processes 25µL samples with a 16-minute incubation at 37°C. The output is a quantitative progesterone concentration value, which clinicians use to assess patient hormone levels. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm performance of freeze-dried calibrators.

Technological Characteristics

Solid-phase immunoassay using enzyme-labeled tracers and luminescence detection. Instrumentation: VITROS Immunodiagnostic System. Calibrators: Freeze-dried, 1 mL reconstitution volume, stored at 2-8°C. Sample type: Human serum and plasma (EDTA or heparin).

Indications for Use

Indicated for the quantitative measurement of progesterone concentration in human serum and plasma (EDTA or heparin) for in vitro diagnostic use.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K032296

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 modification was for changing the set of three calibrators from ready-to-use to freeze dried, requiring reconstitution in 1 ml deionized water.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics.
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.

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.