ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05

K042335 · Bio-Rad Laboratories, Inc. · JJY · Sep 17, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042335
• Device Name: ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Total PSA MasterCheck is intended for use in the verification of sensitivity, calibration linearity and reportable range of the Total PSA assay on the Abbott ARCHITECTi System. Free PSA MasterCheck is intended for use in the verification of sensitivity, calibration linearity and reportable range of the Free PSA assay on the Abbott ARCHITECTi System.

Device Story

Architect Total PSA MasterCheck and Architect Free PSA MasterCheck are quality control materials used in clinical laboratory settings. Total PSA MasterCheck consists of 4 levels of human PSA in HEPES buffer with bovine stabilizer; Free PSA MasterCheck consists of 3 levels of human PSA in HEPES buffer with bovine stabilizer. Devices are used by laboratory technicians to verify assay sensitivity, calibration linearity, and reportable range on the Abbott ARCHITECTi System. Output is a verification of system performance against assigned values provided in the kit data sheet, ensuring accuracy of patient PSA testing results.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Liquid quality control material. Total PSA MasterCheck: 4 levels (HEPES buffer, bovine stabilizer, human PSA). Free PSA MasterCheck: 3 levels (HEPES buffer, bovine stabilizer, human PSA). Designed for use on Abbott ARCHITECTi System. No specific ASTM standards or energy sources cited.

Indications for Use

Indicated for use as quality control material to verify sensitivity, calibration linearity, and reportable range of Total PSA and Free PSA assays on the Abbott ARCHITECTi System.

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

• Architect Progesterone MasterCheck (K990393)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k042335

B. Purpose for Submission:
New device

C. Analyte:
Total PSA and Free PSA

D. Type of Test:
Quality Control Material

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
Architect Total PSA MasterCheck
Architect Free PSA MasterCheck

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

H. Intended Use:
1. Intended use(s):
Total PSA MasterCheck is intended for use in the verification of sensitivity, calibration linearity and reportable range of the Total PSA assay on the Abbott ARCHITECTi System.
Free PSA MasterCheck is intended for use in the verification of sensitivity, calibration linearity and reportable range of the Free PSA assay on the Abbott ARCHITECTi System.
2. Indication(s) for use:
Same as Intended use(s)
3. Special condition for use statement(s):
Not applicable
4. Special instrument Requirements:
Abbott ARCHITECTi System.

I. Device Description:
The Architect Total PSA MasterCheck consists of 4 bottles of controls. Level 0 contains HEPES buffer with bovine stabilizer. Levels 1, 2, 3 and 4 contain different concentrations of total PSA (human) in HEPES buffer with bovine stabilizer and preservatives. The Architect Free PSA MasterCheck consists of 3 bottles of controls. Level 0 contains HEPES buffer with bovine stabilizer.

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Levels 1, 2 and 3 contain different concentrations of free PSA (human) in HEPES buffer with bovine stabilizer and preservatives. Each kit is supplied with a package insert that contains instruction for use, information on storage conditions and shelf life and a data sheet. The data sheet has the assigned values for each level of controls.

## J. Substantial Equivalence Information:

1. Predicate device name(s):
Abbott ARCHITECT Progesterone MasterCheck
2. Predicate K number(s):
k990393
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Intended for use in the verification of sensitivity, calibration, linearity and reportable range of the assay on the Abbott ARCHITECTi System | Same |
| Form | Liquid | Same |
| Open Vial Stability | 3 days at 2℃ to 8℃ | Same |
| Unopened Stability | 2℃ to 8℃ until expiration date | Same |
| Differences | | |
| Item | Device | Predicate |
| Analyte | Free PSA or Total PSA | Progesterone |
| Matrix | HEPES buffer with bovine | Human serum |

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

None referenced

## 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 (controls, calibrators, or method):
The controls are not traceable to any recognized reference material. Value assignments were performed according to Abbott’s testing protocols for MasterCheck control products.

d. Detection limit:
Not applicable

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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. Conclusion:
The submitted material in this premarket notification is complete and supports a substantial equivalence decision