ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR

K041687 · Abbott Laboratories · JJX · Aug 18, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041687
• Device Name: ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR
• Applicant: Abbott Laboratories
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 18, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Abbott ARCHITECT® Estradiol Controls (LN 6C22) are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of estradiol in human serum and plasma. Abbott ARCHITECT® Estradiol Controls (LN 2K25) are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of estradiol in human serum and plasma. Abbott AxSYM® Estradiol Controls are for the estimation of test precision and the detection of systematic analytical deviations of the AxSYM system when used for the quantitative determination of estradiol in human serum. Abbott FSH Controls are for the verification of the precision and accuracy of the ARCHITECT, AxSYM and IMx systems when used for the quantitative determination of follicle stimulating hormone (FSH) in human serum and plasma. Abbott ARCHITECT® LH Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of human luteinizing hormone (LH) in human serum and plasma. Abbott ARCHITECT® Prolactin Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of prolactin in human serum and plasma. Abbott ARCHITECT® Progesterone Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of progesterone in human serum and plasma. Abbott ARCHITECT® Estradiol Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of estradiol in human serum and plasma.

Device Story

Assayed quality control materials and calibrators for Abbott ARCHITECT, AxSYM, and IMx immunoassay systems; used to verify precision, accuracy, and calibration of quantitative hormone assays (estradiol, FSH, LH, prolactin, progesterone). Materials are serum/plasma-based; stored at 2-8°C. Operated by laboratory personnel in clinical settings. Output used by clinicians to monitor assay performance and ensure validity of patient hormone measurements; supports clinical decision-making for diagnosis and treatment of endocrine and reproductive disorders.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Serum/plasma-based quality control and calibrator materials. Storage at 2-8°C (progesterone also at -10°C). Traceable to WHO, USP, or internal reference standards. No active energy source or software; used as reagents in automated immunoassay systems.

Indications for Use

Indicated for use in clinical laboratory settings to estimate test precision and detect systematic analytical deviations (controls) or establish reference points (calibrators) for quantitative hormone assays (Estradiol, FSH, LH, Prolactin, Progesterone) in human specimens. Used for diagnosis/treatment of hormonal sexual, pituitary, gonadal, ovarian, and placental disorders.

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.

Submission Summary (Full Text)

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KC41687

# AUG 1 8 2004

## 510(k) Summary Abbott Immunoassay/Clinical Chemistry Single Analyte Quality Control Materials (assayed) and Abbott ARCHITECT® Estradiol Calibrators

## Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

Name of Submitter: Abbott Laboratories 100 Abbott Park Road Abbott Park, Illinois 60064-3500 Contact Person: Kent Smith Sr. Regulatory Affairs Specialist ADD Regulatory Affairs [phone] Fax [phone]

## Date of Preparation of 510(k) Summary: June 21, 2004

#### Trade Name(s):

| Trade Name | Common<br>Name | Device<br>Classification | Classification<br>Panel | Product<br>Code | Regulation<br>Number |
|---------------------------------------------------------|-----------------------------------------------|--------------------------|-------------------------------|-----------------|----------------------|
| Abbott<br>ARCHITECT®<br>Estradiol Controls<br>(LN 6C22) | Single<br>Analyte QC<br>Material<br>(assayed) | Class I | Clinical<br>Chemistry<br>(75) | JJX | 862.1660 |
| Abbott<br>ARCHITECT®<br>Estradiol Controls<br>(LN 2K25) | Single<br>Analyte QC<br>Material<br>(assayed) | Class I | Clinical<br>Chemistry<br>(75) | JJX | 862.1660 |
| Abbott AxSYM®<br>Estradiol Controls | Single<br>Analyte QC<br>Material<br>(assayed) | Class I | Clinical<br>Chemistry<br>(75) | JJX | 862.1660 |
| Abbott FSH Controls | Single<br>Analyte QC<br>Material<br>(assayed) | Class I | Clinical<br>Chemistry<br>(75) | JJX | 862.1660 |
| Abbott<br>ARCHITECT® LH<br>Controls | Single<br>Analyte QC<br>Material<br>(assayed) | Class I | Clinical<br>Chemistry<br>(75) | JJX | 862.1660 |

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| Trade Name | Common<br>Name | Device<br>Classification | Classification<br>Panel | Product<br>Code | Regulation<br>Number |
|--------------------------------------------------|-----------------------------------------------|--------------------------|-------------------------------|-----------------|----------------------|
| Abbott<br>ARCHITECT®<br>Prolactin Controls | Single<br>Analyte QC<br>Material<br>(assayed) | Class I | Clinical<br>Chemistry<br>(75) | JJX | 862.1660 |
| Abbott<br>ARCHITECT®<br>Progesterone<br>Controls | Single<br>Analyte QC<br>Material<br>(assayed) | Class I | Clinical<br>Chemistry<br>(75) | JJX | 862.1660 |
| Abbott<br>ARCHITECT®<br>Estradiol Calibrators | Calibrator | Class II | Clinical<br>Chemistry<br>(75) | JIT | 862.1150 |

## Device Description:

Abbott Immunoassay/Clinical Chemistry Single Analyte Quality Control Materials (assayed) are devices intended for medical purposes for use in Abbott test systems to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of values in the measurement of substances in human specimens.

Abbott ARCHITECT® Estradiol Calibrators are devices intended for medical purposes for use in Abbott assay test systems to establish points of reference that are used in the quantitative determination of values in the measurement of substances in human specimens.

### Conclusion:

Substantial equivalence is claimed to the legally marketed device as presented in the table below. In addition substantial equivalence has been demonstrated via the use of the FDA Guidance for Industry "Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material" draft guidance released for comment on February 3, 1999 for the Abbott Immunoassay/Clinical Chemistry Single Analyte Quality Control Materials (assayed) and "Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators" issued on February 22, 1999 for the Abbott ARCHITECT® Estradiol Controls.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the bird-like figure.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 8 2004

Mr. Kent Smith Sr. Regulatory Affairs Specialist Abbott Diagnostic Division ADD Regulatory Affairs D-09VA, Building AP6C 100 Abbott Park Road Abbott Park, IL 60064-3500

k041687 Re:

Trade/Device Name: Abbott ARCHITECT® Estradiol Controls (LN 6C22) Abbott ARCHITECT® Estradiol Controls (LN 2K25 Abbott AxSYM® Estradiol Controls Abbott FSH Controls Abbott ARCHITECT® LH Controls Abbott ARCHITECT® Prolactin Controls Abbott ARCHITECT® Progesterone Controls Abbott ARCHITECT® Estradiol Calibrators Regulation Number: 21 CFR 862.1150

Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, JJX Dated: July 26, 2004 Received: July 27, 2004

#### Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced We have letermined the device is 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 application (PMA). You may, therefore, market the device, 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 device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be If your do nec is one additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies 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 Act 3 requirements and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter 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 information about the application of labeling requirements to your device, or guestions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety 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,

Stain M. Cooper, US, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology 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):___KQ41687

Abbott ARCHITECT® Estradiol Controls (LN 6C22) Device Name: Abbott ARCHITECT® Estradio! Controls (LN 2K25) Abbott AxSYM® Estradiol Controls Abbott FSH Controls Abbott ARCHITECT® LH Controls Abbott ARCHITECT® Prolactin Controls Abbott ARCHITECT® Progesterone Controls Abbott ARCHITECT® Estradiol Calibrators

Indications For Use:

Abbott ARCHITECT® Estradiol Controls (LN 6C22) are devices intended for use in the ARCHITECT® Estradiol assay test system to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of estradiol in human specimens. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

Abbott ARCHITECT® Estradiol Controls (LN 2K25) are devices intended for use in the ARCHITECT® Estradiol assay test system to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of estradiol in human specimens. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

Abbott AxSYM® Estradiol Controls are devices intended for use in the AxSYM® Estradiol assay test system to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of estradiol in human specimens. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

Abbott FSH Controls are devices intended for use in the ARCHITECT, AxSYM, and IMx FSH assay test systems to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of folliclestimulating hormone (FSH) in human specimens. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders

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Abbott ARCHITECT® LH Controls are devices intended for use in the ARCHITECT LH assay test system to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of luteinizing hormone (LH) in human specimens. LH measurements are used in the diagnosis and treatment of gonadal function.

Abbott ARCHITECT® Prolactin Controls are devices intended for use in the ARCHITECT Prolactin assay test system to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of prolactin in human specimens. Prolactin measurements are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.

Abbott ARCHITECT® Progesterone Controls are devices intended for use in the ARCHITECT® Progesterone assay test system to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of progesterone in human specimens. Progesterone measurements are used in the diagnosis and treatment of disorders of the ovaries or placenta.

Abbott ARCHITECT® Estradiol Calibrators are devices intended for use in the ARCHITECT® Estradiol assay test system to establish points of reference that are used in the quantitative determination of estradiol in human specimens. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.

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)

Alberto C

Division Sian-Of

Office of In Vitro Diagnostic Device Evaluation ar

510(k) K041687

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