BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS

K061139 · Bayer Healthcare, LLC · JIT · Jul 6, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061139
• Device Name: BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
• Applicant: Bayer Healthcare, LLC
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jul 6, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

For in vitro diagnostic use in the calibration of quantitative PSA assays on the ADVIA® IMS system. For in vitro diagnostic use in the calibration of quantitative complexed PSA assays on the ADVIA® IMS system.

Device Story

The ADVIA® IMS PSA and cPSA Calibrators are liquid, bovine serum-based products used to calibrate quantitative PSA and cPSA assays on the ADVIA® IMS system. The PSA calibrator consists of six levels (0, 2, 10, 25, 50, and 100 ng/mL). The cPSA calibrator values are lot-specific. These calibrators are used in clinical laboratory settings by trained personnel to ensure the accuracy of PSA measurements, which are used in the clinical management of prostate conditions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Bovine serum-based liquid calibrators. PSA levels: 0, 2, 10, 25, 50, 100 ng/mL. cPSA levels: lot-specific. Storage: 2-8°C (PSA); <= -10°C (cPSA). Traceable to Stanford University PSA reference material.

Indications for Use

Indicated for use as calibrators for quantitative PSA and complexed PSA (cPSA) assays on the ADVIA® IMS system. 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

• Lipoprotein Calibrator (K051619)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k061139

B. Purpose for Submission:
New device

C. Measurand:
PSA and cPSA calibrators

D. Type of Test:
Calibrators

E. Applicant:
Bayer Diagnostics

F. Proprietary and Established Names:
ADVIA® IMS PSA Calibrator and ADVIA® IMS cPSA Calibrator

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

H. Intended Use:
1. Intended use(s):
ADVIA® IMS PSA Calibrator: For in vitro diagnostic use in the calibration of quantitative PSA assays on the ADVIA® IMS system.
ADVIA® IMS cPSA Calibrator: For in vitro diagnostic use in the calibration of quantitative complexed PSA assays on the ADVIA® IMS system.
2. Indication(s) for use:
Same as Intended use.
3. Special conditions for use statement(s):
For prescription use only.
4. Special instrument requirements:
ADVIA® IMS system

I. Device Description:
The Bayer ADVIA® IMS PSA Calibrator and ADVIA® IMS cPSA Calibrators are prepared in bovine serum with non-serum constituents added. There are six PSA levels each for the ADVIA® IMS PSA and cPSA Calibrators. The levels for PSA Calibrator are 0, 2, 10, 25, 50 and 100 ng/mL. The cPSA Calibrator values are assigned to specific lots and are not assigned specific values.

J. Substantial Equivalence Information:
1. Predicate device name(s):
Lipoprotein Calibrator
2. Predicate 510(k) number(s):

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k051619

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | Bayer PSA and cPSA calibrators are intended for in vitro diagnostic use to calibrate PSA and cPSA assays on the ADVIA® IMS system | Bayer Lipoprotein calibrators are intended for in vitro diagnostic use to calibrate apolipoprotein A1 and apolipoprotein B assays on the ADVIA® IMS system |
| Levels | Six levels | same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Constituent analytes | PSA in the ADVIA® IMS PSA Calibrator and cPSA in ADVIA® IMS cPSA Calibrator | Apolipoprotein A1 Apolipoprotein B HDL Cholesterol |
| Format | Bovine serum based Liquid form (cPSA calibrators are stored frozen). ready to use. | Mixture of human and bovine serum based Lyophilized |
| Stability | PSA Calibrators: Stable until the expiration date on the label when unopened and stored at 2-8°C Stable for 30 days when opened and stored at 2-8°C cPSA Calibrators: Stable until the expiration date on the label when unopened and stored at <= -10°C Stable for 35 days when opened and stored at 2-8°C. | Stable at 2-8°C until the expiration date printed on the label. Stable 3 days when reconstituted and stored at 2-8°C. |

K. Standard/Guidance Document Referenced (if applicable):

Abbreviated 510(k) submissions for In Vitro Diagnostic Calibrators.

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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
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The ADVIA IMS PSA and cPSA calibrators are traceable to Stanford University prostate specific antigen reference material which consists of 90% purified PSA-α₁-antichymotrypsin (ACT) and 10% free PSA (90:10) mixture on a molar basis.

Stability:

PSA Calibrators:
Unopened calibrators are stable when stored at 2-8°C, until the expiration date on the label.
Opened calibrators are stable for 30 days, when stored at 2-8°C.

cPSA Calibrators:
Unopened calibrators are stable when stored at &lt;= -10°C in a non frost-free freezer, until the expiration date on the label.
Opened calibrators are stable for 35 days, when stored at 2-8°C.

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:
Not applicable.

5. Expected values/Reference range:
Not applicable.

N. Proposed Labeling:

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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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