ADVIA IMS CPSA CONTROL

K061137 · Bayer Healthcare, LLC · JJY · Jul 6, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061137
• Device Name: ADVIA IMS CPSA CONTROL
• Applicant: Bayer Healthcare, LLC
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 6, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

For in vitro diagnostic use to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems. For prescription use only.

Device Story

Bayer ADVIA® IMS cPSA Controls are bovine serum-based quality control materials containing cPSA analyte; used to monitor precision and accuracy of quantitative cPSA assays on ADVIA® IMS and Bayer Immuno1® systems. Kit includes three levels: Level 1 at clinically significant decision point; Level 3 at upper analytical range; Level 2 at intermediate level. Used by laboratory personnel in clinical settings to verify assay performance. Traceable to Stanford University PSA reference material (90:10 PSA-α₁-antichymotrypsin to free PSA ratio).

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Bovine serum-based matrix with added cPSA analyte. Liquid, ready-to-use format. Three-level concentration design. Traceable to Stanford University PSA reference material (90:10 molar ratio of PSA-ACT to free PSA). Storage: <= -10°C (unopened), 2-8°C (opened).

Indications for Use

Indicated for in vitro diagnostic use to monitor the precision and accuracy of quantitative complexed PSA assays on ADVIA IMS and Bayer Immuno1 systems.

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

• Bayer Special Chemistry Controls (k033379)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k061137

B. Purpose for Submission:
New device

C. Measurand:
Controls for complexed PSA (cPSA)

D. Type of Test:
Assayed Quality Control material

E. Applicant:
Bayer Diagnostics

F. Proprietary and Established Names:
Bayer ADVIA® IMS cPSA Controls

G. Regulatory Information:
1. Regulation section:
21 CFR §862.1660, Quality Control Material (assayed and unassayed)
2. Classification:
Class I, reserved
3. Product code:
JJY, Multi-analyte controls, all kinds (assayed and unassayed)
4. Panel:
Chemistry (75)

H. Intended Use:
1. Intended use(s):
For in vitro diagnostic use to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems.
2. Indication(s) for use:
For in vitro diagnostic use to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems.
3. Special conditions for use statement(s):
For prescription use only.
4. Special instrument requirements:
ADVIA® IMS system and Bayer Immuno1® system

I. Device Description:
The Bayer ADVIA® IMS cPSA Controls are bovine serum based with non-serum constituents added. The analyte in the control material is cPSA. The cPSA control kit consists of three different levels of control materials. Level 1 control is manufactured to a clinically significant decision point, between normal and patient groups. Level 3 control is manufactured to the upper analytical range of the assay. Level 2 control is manufactured to a level in between Level 1 and Level 3 controls.

J. Substantial Equivalence Information:
1. Predicate device name(s):

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Bayer Special Chemistry Controls

2. Predicate 510(k) number(s):
k033379

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | Bayer ADVIA® IMS cPSA Controls are intended for in vitro diagnostic use to monitor the precision and the accuracy of the assayed, quantitative complexed PSA method on immunoassay systems including the ADVIA® IMS and Bayer Immuno1® systems | Bayer special chemistry controls are intended for in vitro diagnostic use in the control of ADVIA chemistry system for certain chemistry methods |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Constituent analytes | cPSA | Acid phosphatase Lactate Lipase Pancreatic Amylase Cholinesterase Total iron binding capacity |
| Format | Bovine serum based with human constituents Liquid form and ready to use. | Human serum based with human and bovine constituents Lyophilized |
| Levels | Three levels | Two levels |
| Stability | 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 7 days when reconstituted and stored at 2-8°C. |

K. Standard/Guidance Document Referenced (if applicable):
Guidance for Industry "Points to consider guidance document on assayed and unassayed quality control material".

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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 cPSA controls are traceable to Stanford University PSA reference material. This standard consists of 90% purified PSA-α₁-antichymotrypsin (ACT) and 10% free PSA (90:10) mixture on a molar basis. Value assignment of production lots is done by a nested study that uses a Master Lot of product traceable to the Stanford PSA standard.

Unopened controls are stable when stored at &lt;= -10°C in a non frost-free freezer, until the expiration date on the label. Opened controls 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:
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.