IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)

K103683 · Siemens Healthcare Diagnostics · JJX · Apr 28, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103683
• Device Name: IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 28, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

For in vitro diagnostic use, for the calibration verification of the IMMULITE®/IMMULITE 1000 Progesterone assay (LKPW). For prescription use only

Device Story

Calibration verification material (CVM) for IMMULITE/IMMULITE 1000 Progesterone assay; consists of four vials containing low, intermediate, and high levels of progesterone in processed human serum plus a progesterone-free sample. Used in clinical laboratory settings by laboratory professionals to verify assay calibration and reportable range. Liquid form, ready to use; stored at 2-8°C. Provides reference points to ensure assay accuracy and performance within established specifications. Helps healthcare providers confirm reliability of patient progesterone test results.

Clinical Evidence

No clinical data. Bench testing only; traceability, value assignment, and stability validated following Siemens Healthcare Diagnostics procedures.

Technological Characteristics

Processed human serum spiked with progesterone; contains preservative (sodium azide <0.1 g/dL). Liquid form, ready-to-use. Storage 2–8°C. Traceable to internal standard using optical density-defined progesterone stock solution. No electronic or software components.

Indications for Use

Indicated for in vitro diagnostic use for calibration verification of the IMMULITE/IMMULITE 1000 Progesterone assay. No specific patient population, age, or gender constraints defined.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material (MCM) (K102904)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVISE ONLY TEMPLATE

A. 510(k) Number:
k103683

B. Purpose for Submission:
New device

C. Measurand:
Quality control materials for the IMMULITE®/IMMULITE 1000 Progesterone assay (LKPW)

D. Type of Test:
Not Applicable

E. Applicant:
Siemens Healthcare Diagnostics, Inc.

F. Proprietary and Established Names:
IMMULITE®/IMMULITE 1000 Progesterone Calibration Verification Material (CVM)

G. Regulatory Information:
1. Regulation section:
21 CFR §862.1660, Quality Control Material (Assayed and Unassayed)
2. Classification:
Class I, Reserved
3. Product code:
JJX – Single (Specified) Analyte Controls (Assayed and Unassayed))
4. Panel:
Clinical Chemistry (75)

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## H. Intended Use:

1. Intended use(s):

See Indications for Use below.

2. Indications(s) for use:

For in vitro diagnostic use, for the calibration verification of the IMMULITE®/IMMULITE 1000 Progesterone assay (LKPW).

3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

IMMULITE®/IMMULITE 1000 system

## I. Device Description:

The Calibration Verification Material (CVM) contains one set of four vials, 2 mL each, spiked with low, intermediate and high levels of progesterone in processed human serum, with preservative, and a progesterone-free sample. The Calibration Verifiers are supplied in liquid form, ready to use. Store unopened materials refrigerated at 2–8°C until expiration date. The product is labeled as stable at 2–8°C for 30 days after opening.

**Warnings and Precautions:** For in vitro diagnostic use. Follow universal precautions, and handle all components as if capable of transmitting infectious agents. Individual source materials derived from human blood were tested by FDA approved/cleared methods and found nonreactive for syphilis; for antibodies to HIV 1 and 2; for hepatitis B surface antigen; and for antibodies to hepatitis C. Sodium azide, at concentrations less than 0.1 g/dL, has been added as a preservative. On disposal, flush with large volumes of water to prevent the buildup of potentially explosive metal azides in lead and copper plumbing.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material (MCM)

2. Predicate 510(k) number(s):

K102904

3. Comparison with predicate:

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| Reagent Similarities and Differences | | |
| --- | --- | --- |
| | Candidate Device
IMMULITE/IMMULITE 1000
Progesterone CVM (k103683) | Predicate Device
ADVIA Centaur Master Curve
Material (k102904) |
| Intended/Indications for Use | is for in vitro diagnostic use in the verification of calibration | Same |
| Specimen Matrix | Human serum | Same |
| Form | Liquid | Lyophilized |
| Analytes | Progesterone | Estradiol |
| Storage | 2 to 8°C | Same |
| Stability | Unopened-until expiration date on the vial label
Opened- 30 days | Unopened-Same
Opened- 14 days |

K. Standard/ Guidance Document Referenced (if applicable):
- Stability Testing of In Vitro Diagnostic Reagents
- Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final
- Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter dated 3/14/1996
- Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA Staff
- Indications for Use Statement
- Premarket Notification - Consistency of Reviews #K89-1 (blue Book memo)

L. Test Principle:
Not Applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Not Applicable
b. Linearity/assay reportable range:
Not Applicable

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c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability:

The IMMULITE Progesterone CVMs are traceable to an internal standard manufactured using qualified materials and measurement procedures. Internal reference standards are prepared using Progesterone stock solution which had its concentration defined by optical density.

Stability:

Stability studies are being conducted on two lots under the following conditions: real time (2-8 °C) for 2 years, room temperature (15-28°C) for seven days, and accelerated (35-39°C) for three days. Current testing supports a seven month storage claim at 2-8°C, and real time studies are ongoing to support a 2 year stability claim.

Open vial studies are being performed for &gt;90 days at 2-8°C. Vials are opened and tested at day zero and at each time point. Percent recovery is calculated using the average dose from triplicate results compared to the day 0 testing and the acceptance criteria is that the open vial must be within 10% from day 0 material for progesterone ≥2 ng/mL, and within 15% for progesterone ≥0.5 ng/mL and &lt;2.0 ng/mL. The sponsor will claim that it is stable for 14 day once reconstituted and stored at 2-8 °C.

Value Assignment

The IMMULITE® calibrators and CVMs are value assigned using purified Progesterone stock solution whose concentration was defined by optical density. The calibrators and CVMs are tested on minimum of 9 runs comprised of minimum 3 systems and 3 different kit lots. The calibrator values are calculated based on the recovered values for each run independently. The average analyte recovered for each CVM assigns their value. Quality control is performed by calculating the recovery of patient sample panels and controls using the assigned calibrator and CVM values. Three levels of commercially available controls and four levels of human serum based pools are used to validate the CVM value assignment. The target specifications for production lots are:

| CVM (ng/mL) | Target (ng/mL) | Range (ng/mL) | Precision (% CV) |
| --- | --- | --- | --- |
| 0 | 0 | 0.0-0.20 | NA |
| 0.47 | 0.47 | 0.26-0.68 | <25 |
| 10 | 10 | 7.9-12.1 | <10 |
| 40 | 40 | 32.4-47.6 | <10 |

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The Sponsor spiked three concentrations of progesterone CVM into a reference lot, evaluation lot, and male and female human serum lots. The progesterone values of the reference lot were compared to the evaluation and human serum lots. The acceptance criteria were 100% ± 15% with an overall average of ±10%. Each of the samples met the acceptance criteria, and the Sponsor concluded that there were no matrix effects.

d. Detection limit:
Not applicable

e. Analytical specificity:
Not Applicable

f. Assay cut-off:
Not Applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not Applicable
b. Matrix comparison:
Not applicable.

3. Clinical studies:
a. Clinical Sensitivity:
Not Applicable
b. Clinical specificity:
Not Applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not Applicable

4. Clinical cut-off:

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Not Applicable

# 5. Expected values/Reference range

The expected values are provided in the IMMULITE/IMMULITE 1000 Progesterone Calibration Verification Material lot-specific value sheet. The expected assay range is $0.2 - 40\mathrm{ng / mL}$ . The values below can be considered as guidelines:

| Level | Units | Target Mean | Guideline ± 2 SD range | |
| --- | --- | --- | --- | --- |
| 1 | ng/mL | 0.00 | 0.00 | ≤ 0.20 |
| 2 | ng/mL | 0.47 | 0.42 | 0.52 |
| 3 | ng/mL | 10.00 | 9.00 | 11.0 |
| 4 | ng/mL | 40.0 | 36.0 | 44.0 |

# N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

# O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.