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

Intended 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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services U.S.A. The logo features a stylized symbol resembling a bird or abstract human figure, composed of three curved lines. The symbol is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the circumference of the circle.

### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## NOV 8 - 2004

Ms. Elizabeth Platt Regulatory Affairs Manager/Quality Assurance Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-1200

Re: k042335

Trade/Device Name: Architect Free PSA MasterCheck Architect Total PSA MasterCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class II Product Code: JJY Dated: August 26, 2004 Received: August 30, 2004

Dear Ms Platt:

This letter corrects our substantially equivalent letter of September 17, 2004 regarding the Architect Free PSA MasterCheck and Architect Total PSA MasterCheck in which the Architect Total PSA MasterCheck was omitted from the listing of the trade name(s).

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are substantially equivalent [{for the indications for use stated in the enclosure)] to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Robert H. Becker Jr.

Robert L. Becker, Jr., M.D., Pk DIRECTOR Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| 510(k) Number (if known): | K042335 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Architect Free PSA MasterCheck |
| Indications For Use: | 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 ARCHITECT System. |
| Device Name: | Architect Total PSA MasterCheck |
| 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 ARCHITECT i System. |

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Division Sign-Off

Office of In Vitte Diagnostic Office Evaluation and Safety

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510(k) K042335

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### Summary of Safety and Effectiveness Architect MasterCheck Controls (PSA and PSA Free)

#### 1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 [phone] Telephone: [phone] Fax:

### Contact Person

Maria Zeballos Regulatory Affairs Specialist [phone] Telephone:

### Date of Summary Preparation

August 26, 2004

### Device Identification 2.0

Product Name:

| Product Name: | Architect Free PSA MasterCheck<br>Architect PSA MasterCheck | | |
|--------------------|-------------------------------------------------------------|--|--|
| Common Name: | Multi-analyte Controls, (Assayed and unassayed) | | |
| Classifications: | Class I | | |
| Product Code: | JJY | | |
| Regulation Number: | 21 CFR 864.1660 | | |

### Device to Which Substantial Equivalence is Claimed 3.0

Architect Progesterone MasterCheck Abbott Laboratories Abbott Park, IL 60064

510 (k) Number: K990393

#### Description of Device 4.0

These are liquid products prepared from HEPES buffer with protein (bovine), constituents of human origin, stabilizers and preservatives. (Level 0 does not contain preservatives or constituents of human origin).

#### Intended Use 5.0

Architect MasteChecks are intended for use in the verification of sensitivity, calibration linearity and reportable range of the Free PSA or Total PSA assay on the Abbott ARCHITECT | System.

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#### Preservatives: 6.0

Architect MasteChecks do not contain sodium azide as a preservative. They contains a Arontest Masteonoons as not cocktail as a preservative where the concentration of any one ingredient is less than 0.1%. At this low level, these ingredients are not expected to cause a health hazard to the user. And thus, domestic and international regulations do not require this type of information on the vial or box label.

### Comparison of the new device with the Predicate Device 7.0

The new Architect MasterCheck products claim substantial equivalence to the Architect Progesterone MasterCheck currently in commercial distribution (K990393). The new Architect MasterCheck products contain either Free PSA or Total PSA analyte.

| Characteristics | Bio-Rad Laboratories<br>Architect Free PSA MasterCheck<br>Architect PSA MasterCheck<br>(New Device) | Abbott Laboratories<br>Architect Progesterone MasterCheck<br>(Predicate Device K990393) |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Free PSA MasteCheck is intended for<br>use in the verification of sensitivity,<br>calibration linearity and reportable<br>range of the Free PSA assay on the<br>Abbott ARCHITECT <i> System</i> | Progesterone MasteCheck is intended for use in the<br>verification of sensitivity, calibration linearity and<br>reportable range of the Progesterone assay on the<br>Abbott ARCHITECT <i> System</i> . |
| | Total PSA MasteCheck is intended for<br>use in the verification of sensitivity,<br>calibration linearity and reportable range<br>of the total PSA assay on the Abbott<br>ARCHITECT <i> System</i> . | |
| Form | Liquid | Liquid |
| Open Vial | 3 days at 2°C to 8°C | 3 days at 2°C to 8°C |
| Storage Stability<br>(Unopened) | 2°C to 8°C<br>Until expiration date | 2°C to 8°C<br>Until expiration date |
| Differences | | |
| Matrix | HEPES buffer with protein (bovine) | Human Serum |
| Analytes | Contains the following analyte:<br>Free PSA (Architect Free PSA MasterCheck) Total PSA (Architect Total PSA MasterCheck) | Contains the following analyte:<br>Progesterone |

Table 1. Similarities and Differences between new and predicate device.

#### 1.0 STATEMENT OF SUPPORTING DATA

Stability studies have been performed to determine the open vial stability and shelf life for these products. Product claims are as follows:

- Open vial Stability: 3 days when stored tightly capped at 2 to 8°C. .
- Shelf Life: Twelve months when stored at 2 to 8 °C .

All supporting data is retained on file at Bio-Rad Laboratories.