← Product Code [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT) · K061139

# BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS (K061139)

_Bayer Healthcare, LLC · JIT · Jul 6, 2006 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K061139

## Device Facts

- **Applicant:** Bayer Healthcare, LLC
- **Product Code:** [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT.md)
- **Decision Date:** Jul 6, 2006
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 862.1150
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## 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.

## Regulatory 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](/device/K051619.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

1

# 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):

{1}

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.

{2}

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:

{3}

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.

4

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K061139](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K061139)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com