ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05

K984324 · Bio-Rad · JJX · Dec 15, 1998 · Clinical Chemistry

Device Facts

• Record ID: K984324
• Device Name: ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05
• Applicant: Bio-Rad
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Architect Prolactin MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Prolactin assay on the Abbott Architect i System.

Device Story

Architect Prolactin MasterCheck is a multi-level liquid control product used in clinical laboratory settings. It consists of a HEPES buffer base with bovine protein stabilizers; levels 1-4 contain human prolactin. The device is used by laboratory technicians to verify the performance of the Abbott Architect i System Prolactin assay. By testing these controls, the user confirms the assay's sensitivity, calibration linearity, and reportable range. This verification process ensures the accuracy of patient test results, allowing healthcare providers to make reliable clinical decisions regarding prolactin levels.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid control; HEPES buffer with bovine protein stabilizers; contains human prolactin (levels 1-4); antimicrobial preservative; storage 2-8°C; open vial stability 3 days at 2-8°C.

Indications for Use

Indicated for use as an in vitro diagnostic control to verify the sensitivity, calibration linearity, and reportable range of the Prolactin assay on the Abbott Architect i System. No specific patient population is described as this is a laboratory control product.

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

• Serum Multi-Analyte Verification Test Set (K950469)

Submission Summary (Full Text)

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DEC 1 5 1998

Image /page/0/Picture/1 description: The image shows the logo for Bio-Rad. The text "BIO-RAD" is written in bold, white letters against a black background. The logo has a rounded, rectangular shape.

Bio-Rad Laboratories

Diannostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: [phone]

K984324

## 510(k) Summary

Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA [phone] Fax [phone]

Contact Person Elizabeth Platt

Date of Summary Preparation December 02, 1998

Device (Trade & Common Name) Architect Prolactin MasterCheck

Classification Name Class 1, 75JJX CFR 862.1660: Single (Specified) Analyte Controls (Assayed and Unassayed)

Devices to Which Substantial Equivalence is Claimed Document Serum Multi-Analyte Verification Test Set Casco Standards Yarmouth, ME K950469

## Statement of Intended Use

Architect Prolactin MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Prolactin assay on the Abbott Architect i System.

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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories. The logo is in black and white, with the words "BIO-RAD" in bold, sans-serif font. The letters are white, and the background is black. The logo is enclosed in a rounded rectangle.

Bio-Rad Laboratories

Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: [phone]

Description of the Device

Architect Prolactin MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.

Architect Prolactin MasterCheck Levels 1, 2, 3 and 4 contain prolactin (human) prepared in HEPES buffer with protein (bovine) stabilizers.

Preservative: Antimicrobial Agent.

Statement of How Technological Characteristics Compare to Substantial Equivalence Device

A table is provided below comparing the similarities between the Bio-Rad Architect Prolactin MasterCheck and the devices to which substantial equivalence is claimed.

| | Architect Prolactin MasterCheck | Casco Standards Document<br>Serum Multi-Analyte<br>Verification Test Set |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | Verification of sensitivity,<br>calibration linearity, and<br>reportable range of the<br>Prolactin assay on the Abbott<br>Architect i System. | In vitro diagnostic use in the<br>quantitative determination of<br>linearity, calibration<br>verification and verification<br>of reportable range using<br>automated, semi-automated<br>and manual methods. |
| Form | Liquid | Liquid |
| Matrix | HEPES buffer with protein<br>(bovine) stabilizers | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | Prolactin | Multiple |
| Open Vial<br>Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the<br>Architect Prolactin assay. | Calibration verifier for<br>multiple analytes. |

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## DEC 15 1998

Ms. Elizabeth Platt Requlatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017

Re : K984324 Architect Prolactin MasterCheck Trade Name: Regulatory Class: I Product Code: JJX Dated: December 2, 1998 Received: December 3, 1998

Dear Ms. Platt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral 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 device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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Paqe 2

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Architect Prolactin MasterCheck

Indications for Use:

Architect Prolactin MasterCheck is intended for use in the verification of sensitive and clastin Master Check is intended for use in the verification of
sensitivity, calibration linearity, and reportable range of the Prolactin assay
on the Abbott Ar on the Abbott Architect i System.

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

(Concurrence of CDRH, Office of Device Evaluation)

| (Division Sign-Off) | |
|-----------------------------------------|--------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | 984324 |

| Prescription Use | <div></div> | OR | Over-The Counter Use | |
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