DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL

K113373 · Siemens Healthcare Diagnostics, Inc. · JIT · Dec 30, 2011 · Clinical Chemistry

Device Facts

• Record ID: K113373
• Device Name: DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 30, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The LOCI 9 CAL is an in vitro diagnostic product for the calibration of the progesterone (PROG) method on the Dimension Vista® System.

Device Story

LOCI 9 Calibrator is a liquid, frozen, bovine serum albumin-based product containing progesterone, testosterone, buffers, and preservatives. It is packaged in ten vials across five levels (A-E). The device is used in a clinical laboratory setting on the Dimension Vista® System to calibrate the progesterone assay. Healthcare professionals use the system to measure progesterone levels in patient samples; the calibrator ensures the accuracy and traceability of these measurements by providing known concentration reference points. This calibration process is essential for the reliable quantification of progesterone, which aids clinicians in assessing patient endocrine status.

Clinical Evidence

No clinical data. Performance validation focused on traceability, value assignment, and stability testing.

Technological Characteristics

Liquid, frozen bovine serum albumin-based matrix. Contains progesterone, testosterone, buffers, and preservatives. Packaged in 1.5 mL vials. Designed for use with the Dimension Vista® System. No software or electronic components.

Indications for Use

Indicated for the calibration of the progesterone (PROG) method on the Dimension Vista® System. For prescription use only.

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.

Predicate Devices

• Siemens Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide Calibrator (k080578)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k113373

B. Purpose for Submission:
New Device

C. Measurand:
Calibrator materials for progesterone

D. Type of Test:
Calibrator material

E. Applicant:
Siemens Healthcare Diagnostics, Inc.

F. Proprietary and Established Names:
Dimension Vista® LOCI 9 Calibrator

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1150; Calibrator
2. Classification:
Class II
3. Product code:
JIT; Calibrator, Secondary
4. Panel:
Clinical Chemistry (75)

H. Intended Use:
1. Intended use(s):
The LOCI 9 CAL is an in vitro diagnostic product for the calibration of the
progesterone (PROG) method on the Dimension Vista® System.
2. Indication(s) for use:
See Intended Use section above
3. Special conditions for use statement(s):
For prescription use only

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4. Special instrument requirements:
Dimension Vista® System

Stability and value assignment studies were performed on the Dimension Vista® 1500 Intelligent Lab System.

I. Device Description:
The LOCI 9 Calibrator is a liquid, frozen bovine serum albumin based product containing progesterone packaged as ten vials to a carton, with two vials at each of the 5 levels (A through E), 1.5 mL per vial. The LOCI 9 Calibrator includes progesterone, testosterone, buffers and preservatives. This calibrator will only be used with the Dimension Vista® Progesterone (PROG) method.

J. Substantial Equivalence Information:
1. Predicate device name(s):
Siemens Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide Calibrator
2. Predicate K number(s):
k080578

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3. Comparison with predicate:

| | Candidate Device Dimension Vista® LOCI 9 Progesterone Calibrator | Predicate Device Dimension Vista® PBNP CAL (k080578) |
| --- | --- | --- |
| Intended use | Same | In vitro diagnostic product for the calibration of analytical methods on the Dimension Vista® System |
| Analyte | Progesterone | Synthetic PBNP |
| Matrix | Same | Bovine serum albumin-based |
| Form | Same | Liquid, frozen |
| # Levels | Ten vials, 2 vials/level, 5 levels (0, 1.0, 8.0, 20.0 and 44.0 ng/mL) | Ten vials, 2 vials/level, 5 levels (0, 250, 1,500, 12,000 and 36, 750 pg/mL) |
| Stability | Unopened-Same
Opened—7 days | Unopened-until expiration date on the vial label
Opened—30 days |
| Fill Volume | 1.5 mL/vial | 1.0 mL/vial |

K. Standard/Guidance Document Referenced (if applicable):
- Guidance for Industry – Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final

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 assigned values for the commercial LOCI 9 calibrator Levels B-E are assigned from the following master pool levels:

| Analyte | Reference assignment of Master pools | Master pool Levels |
| --- | --- | --- |
| Progesterone | Progesterone GC-IDMS* | 0.97, 8.97, 17.2 and 43.8 ng/mL |

*Gas chromatographic isotope dilution mass spectrometry

The zero calibrator for the progesterone master pool is fatty acid free bovine serum albumin calibrator base.

Stability:

Real Time/Closed Vial Stability: Target shelf-life for the Dimension Vista® LOCI 9 calibrators is 12 months when frozen (-15°C to -25°C). Shelf life is determined by comparing results of the calibrator levels stored at -15°C and -25°C with control calibrators stored at -70°C on intervals ranging from 0 to 395 days. Five replicates per level are tested. Three production (test) and control (reference) lots of calibrator were tested for stability.

Thawed 2-8°C Closed Vial Stability: 7 days at 2-8°C.

Punctured/Open Vial Stability: Punctured vials are stable for 7 days when stored on board the Dimension Vista® System. Once the cap is removed, the product is stable for 7 days when recapped and stored at 2-8°C.

Acceptance Criteria: The reference material (control calibrator) is stored at -70°C. The method is calibrated from this stored material. The -15°C and -25°C calibrator levels are recovered from the control calibration. Recoveries vs. time are monitored and allowable drift (% change in control vs. test calibrators) was ≤ 5% deviation from reference concentration for levels B-E.

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Value Assignment:

The values of the LOCI 9 Calibrators are assigned by creating anchor pools from individual serum patient samples covering the assay range for progesterone that are assayed by GC-IDMS. The four level Master Pools are prepared by spiking commercially purified progesterone in bovine serum albumin (BSA) and assigning values on the Dimension Vista® 1500 Intelligent Lab System prior to storing at -70°C. A progesterone stock solution is made by spiking commercially available progesterone material gravimetrically into a BSA calibrator base at appropriate concentrations for levels B-E. The concentration of the bulk commercial calibrator is verified by measuring recovery on a Dimension Vista® instrument calibrated with Progesterone Master Pools. The final bottle values for commercial lots are assigned against the master pool curves using multiple instruments and reagent lots, where values must be within acceptable ranges of the target for levels B-E. The bottle value for each level is the mean of 45 replicates.

The attached table outlines the target range at each level as well as the acceptable range and precision around the target.

| LOCI 9 Calibrator KC647
Progesterone Method Range 0 to 40 ng/mL | | | |
| --- | --- | --- | --- |
| Level | Target | Range ng/mL | Level Precision |
| A | 0 | < 0.2 ng/mL | < 0.2 ng/mL |
| B | 1.0 | 0.9 to 1.1 | ≤ 3% |
| C | 8.0 | 7.2 to 8.8 | ≤ 3% |
| D | 20.0 | 18.0 to 22.0 | ≤ 3% |
| E | 44.0 | 39.6 – 48.4 | ≤ 3% |

d. Detection limit: Not applicable
e. Analytical specificity: Not applicable
f. Assay cut-off: Not applicable

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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: Not applicable

5. Expected values/Reference range: Not applicable

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.

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