ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT

K032458 · Abbott Laboratories · JIT · Oct 6, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032458
• Device Name: ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT
• Applicant: Abbott Laboratories
• Product Code: JIT · Clinical Chemistry
• Decision Date: Oct 6, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

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. Abbott AxSYM Estradiol Standard Calibrators and AxSYM Estradiol Master Calibrators are devices intended for use in the AxSYM 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. Abbott ARCHITECT FSH Calibrators are devices intended for use in the ARCHITECT FSH assay test system to establish points of reference that are used in the quantitative determination of follicle-stimulating hormone (FSH) in human specimens. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal discorders ARCHITECT LH Calibrators are devices intended for use in the ARCHITECT LH assay test system to establish points of reference 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. ARCHITECT Progesterone Calibrators are devices intended for use in the ARCHITECT Progesterone assay test system to establish points of reference 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. ARCHITECT Prolactin Calibrators are devices intended for use in the ARCHITECT Prolactin assay test system to establish points of reference 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 AxSYM Total T3 Standard Calibrators and AxSYM Total T3 Master Calibrators are devices intended for use in the AxSYM Total T3 assay test system to establish points of reference that are used in the quantitative determination of total T3 in human specimens. Total T3 measurements are used in the diagnosis and treatment of thyroid disease.

Device Story

Calibrators function as reference standards for Abbott ARCHITECT and AxSYM immunoassay systems; establish calibration curves for quantitative measurement of hormones (estradiol, FSH, LH, progesterone, prolactin) and thyroid hormone (T3) in human specimens. Used in clinical laboratory settings by trained technicians. Input: calibrator material of known concentration; Output: reference points for assay system. Healthcare providers use resulting quantitative values to diagnose/treat endocrine, reproductive, and thyroid conditions. Benefits: ensures accuracy and consistency of patient test results.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing and adherence to FDA Guidance for Industry 'Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators'.

Technological Characteristics

Calibrators consist of hormone-spiked matrices (Tris buffer, bovine serum, or human serum). Standardization achieved via gravimetric manufacturing and referencing to WHO International Standards or internal standards verified by HPLC/GCMS. Form factor: multi-level liquid calibrators. Connectivity: N/A (reagent component).

Indications for Use

Indicated for use as reference points in quantitative immunoassays for estradiol, FSH, LH, progesterone, prolactin, and total T3 in human specimens to aid in the diagnosis and treatment of hormonal, reproductive, pituitary, placental, and thyroid disorders.

Regulatory Classification

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

• IMx® Estradiol Calibrators (K951629)
• Abbott FSH Calibrators (K890135)
• AxSYM® LH Standard Calibrators (K935611)
• AxSYM® Progesterone Standard Calibrators (K955025)
• Abbott Prolactin Calibrators (K896162)
• Ciba-Corning ACS:180 Prolactin Assay Calibrator (K934517)
• AxSYM® Total T3 Standard and Master Calibrators

Submission Summary (Full Text)

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K032458

OCT = 6 2003

# 510(k) Summary Immunoassay/Clinical Chemistry Calibrators

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

| Name of Submitter: | Abbott Laboratories |
|----------------------------------------|---------------------------------------------------|
| | 200 Abbott Park Road |
| | Abbott Park, Illinois 60064-6187 |
| Contact Person: | Denise Farmer |
| | Sr. Regulatory Affairs Specialist |
| | ADD Regulatory Affairs |
| | [phone] |
| | Fax [phone] |
| Date of Preparation of 510(k) Summary: | September 25, 2003 |
| Trade Name(s): | Abbott ARCHITECT® Estradiol Calibrators |
| | Abbott AxSYM® Estradiol Standard Calibrators |
| | Abbott AxSYM® Estradiol Master Calibrators |
| | Abbott ARCHITECT® FSH Calibrators |
| | Abbott ARCHITECT® LH Calibrators |
| | Abbott ARCHITECT® Progesterone Calibrators |
| | Abbott ARCHITECT® Prolactin Calibrators |
| | Abbott AxSYM® Total T3 Standard Calibrators |
| | Abbott AxSYM® Total T3 Master Calibrators |
| Common Name: | Abbott Immunoassay/Clinical Chemistry Calibrators |
| Device Classification: | Class II |
| Classification Panel: | Clinical Chemistry (75) |
| Product Code: | JIT |

### Device Description:

Abbott Immunoassay/Clinical Chemistry 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 "Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators" issued on February 22, 1999,

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| | | | Differences |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Calibrator Name<br>ARCHITECT Estradiol<br>Calibrators | Predicate Device<br>IMx Estradiol Calibrators<br>(K951629) | Similarities<br>Both are calibrators intended to establish<br>●<br>points of reference.<br>Both are for use with quantitative<br>immunoassays which detect Estradiol<br>Both are Tris Buffer based.<br>●<br>Both are standardized to an internal<br>reference standards using Estradiol<br>(purity no less than 97% by HPLC). | IMx Estadiol Calibrators contain<br>6 levels (0, 50, 250, 750, 1500,<br>3000 pg/mL) intended to<br>establish points of reference.<br>ARCHITECT Estradiol<br>●<br>Calibrators contain 2 levels (0,<br>1600 pg/mL). |
| AxSYM Estradiol Standard<br>Calibrators<br>AxSYM Estradiol Master<br>Calibrators | IMx Estradiol Calibrators<br>(K951629) | Both are calibrators intended to establish<br>points of reference.<br>Both are for use with quantitative<br>immunoassays which detect Estradiol<br>Both are Tris Buffer based.<br>●<br>Both contain 6 levels that are intended to<br>●<br>establish points of reference. | IMx Estradiol Calibrators are<br>standardized to an internal<br>reference standards using<br>Estradiol (purity no less than<br>97% by HPLC).<br>AxSYM Estradiol Calibrators are<br>standardized to an internal<br>reference standard for AxSYM<br>Estradiol. These internal<br>standards are standardized to<br>correlate with gas<br>chromatography/mass<br>spectrometry (GCMS).<br>IMx Estadiol Calibrators contain<br>6 levels at (0, 50, 250, 750, 1500,<br>3000 pg/mL) intended to<br>establish points of reference.<br>AxSYM Estradiol Standard<br>Calibrators contain 6 levels (0,<br>50, 100, 200, 500, 1000 pg/mL)<br>intended to establish points of<br>reference.<br>AxSYM Estradiol Master<br>●<br>Calibrators contain 2 levels (0,<br>200 pg/mL) intended to establish<br>points of reference. |
| ARCHITECT FSH<br>Calibrators | Abbott FSH Calibrators<br>(K890135) | Both are calibrators intended to establish<br>●<br>points of reference.<br>Both are for use with quantitative<br>●<br>immunoassays, which detect FSH.<br>Both are Bovine serum based.<br>Both sets of calibrators are manufactured<br>by addition of Follicle Stimulating<br>Hormone (FSH) of known concentration<br>to obtain a target concentration. The<br>concentration is referenced against World<br>Health Organization (WHO) FSH 2nd<br>International Reference Preparation (IRP)<br>78/549. | ARCHITECT FSH Calibrators<br>contain 2 levels (0, 100 mIU/mL)<br>intended to establish points of<br>reference.<br>Abbott FSH Calibrators contain<br>●<br>6 levels (0, 1, 10, 50, 100, 150<br>mIU/mL). |
| ARCHITECT LH<br>Calibrators | AxSYM LH Standard<br>Calibrators (K935611) | Both are calibrators intended to establish<br>points of reference.<br>Both are for use with quantitative<br>immunoassays, which detect LH.<br>Both are calf serum based.<br>●<br>Both sets are of calibrators are<br>●<br>manufactured gravimetrically and<br>referenced to the World Health<br>Organization (WHO) Luteinizing<br>Hormone (LH) Human, Pituitarv 2nd | ARCHITECT LH Calibrators<br>contain 2 levels (2, 100 mIU/mL)<br>intended to establish points of<br>reference.<br>AxSYM LH Calibrators contain<br>●<br>6 levels (0, 2, 10, 25, 100, 250<br>mIU/mL). |
| Calibrator Name | Predicate Device | Similarities | Differences |
| ARCHITECT Progesterone<br>Calibrators | AxSYM Progesterone Standard<br>Calibrators (K955025) | International Standard 80/552 at each<br>concentration.<br>● Both are calibrators intended to establish<br>points of reference.<br>● Both are for use with quantitative<br>immunoassays, which detect<br>Progesterone. | ● The ARCHITECT Progesterone<br>Calibrators contain 2 levels (0.7,<br>40.0 ng/mL).<br>● The AxSYM Progesterone<br>Standard Calibrators contain 6<br>levels (0, 0.7, 2, 7, 20, 40<br>ng/mL).<br>● The ARCHITECT Progesterone<br>Calibrators are human serum<br>based.<br>● The AxSYM Progesterone<br>Standard Calibrators are serum<br>based for Level 0 and Tris buffer<br>based for the remaining levels. |
| ARCHITECT<br>Prolactin<br>Calibrators | Abbott Prolactin Calibrators<br>(K896162) | ● Both are calibrators intended to establish<br>points of reference.<br>● Both are for use with quantitative<br>immunoassays which detect Prolactin.<br>● Both are referenced to the World Health<br>Organization (WHO) 3rd International<br>Standard 84/500 for Prolactin at each<br>concentration level.<br>● Both are Tris buffer based. | ● The ARCHITECT Prolactin<br>Calibrators contain 2 levels (5,<br>30 ng/mL).<br>● The Abbott Prolactin Calibrators<br>contain 6 levels (0, 5, 10, 30, 80,<br>200 ng/mL). |
| AxSYM Total T3 Standard<br>Calibrators (LN 7A52-02)<br>AxSYM Total T3 Master<br>Calibrators (LN 7A52-32)<br>which are Calibrators A and<br>C of the Standard<br>Calibrators | AxSYM Total T3 Standard<br>Calibrators (K934517)<br>AxSYM Total T3 Master<br>Calibrators which are<br>Calibrators A and C of the<br>Standard Calibrators<br>(K934517) | ● Both are calibrators intended to establish<br>points of reference.<br>● Both are for use with quantitative<br>immunoassays, which detect Total T3.<br>● Both contain 6 levels (0, 0.5, 1, 2, 4, 8<br>ng/mL) for the Standard Calibrators and<br>2 levels (0, 1 ng/mL) for the Master<br>Calibrators.<br>● Both are bovine serum based. | ● AxSYM Total T3 Standard<br>Calibrators LN 7A52-02 and<br>AxSYM Total T3 Master<br>Calibrators 7A52-32 are<br>manufactured using L-<br>Triiodothyronine, sodium salt,<br>(USP Grade) and signal matched<br>to Abbott internal reference<br>standards which are traceable to<br>the USP Reference Standard L-<br>Triiodothyronine (free acid) at<br>each concentration level. The<br>concentration of the T3 stock<br>solution used to make the<br>internal reference standards is<br>determined by HPLC.<br>● AxSYM Total T3 Standard<br>Calibrators and AxSYM Total<br>T3 Master Calibrators (K934517)<br>are standardized as follows:<br>Abbott manufactures internal<br>reference standards for Total T3<br>using L-Triiodothryonine<br>Sodium (HPLC purity 95.0-<br>101.0%). Total T3 primary and<br>secondary calibrators are<br>manufactured gravimetrically<br>utilizing this internal reference<br>standard. All list material is<br>tested against these primary and<br>secondary calibrators. |

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes representing the feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

OCT - 6 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Denise Farmer Sr. Regulatory Affairs Specialist Abbott Laboratories ADD Regulatory Affairs Dept 9V6, Bldg. AP34-2 200 Abbott Park Road Abbott Park, IL 60064-6187

Re: k032458

Trade/Device Name: Abbott ARCHITECT® Estradiol Calibrators Abbott AxSYM® Estradiol Standard Calibrators Abbott AxSYM® Estradiol Master Calibrators Abbott ARCHITECT® FSH Calibrators Abbott ARCHITECT® LH Calibrators Abbott ARCHITECT® Progesterone Calibrators Abbott ARCHITECT® Prolactin Calibrators Abbott AxSYM® Total T3 Standard Calibrators Abbott AxSYM® Total T3 Master Calibrators

Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: September 15, 2003 Received: September 16, 2003

#### Dear Ms. Farmer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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.

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director 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):____K032458_

Abbott ARCHITECT® Estradiol Calibrators Device Name: Abbott AxSYM® Estradiol Standard Calibrators Abbott AxSYM® Estradiol Master Calibrators Abbott ARCHITECT® FSH Calibrators Abbott ARCHITECT® LH Calibrators Abbott ARCHITECT® Progesterone Calibrators Abbott ARCHITECT® Prolactin Calibrators Abbott AxSYM® Total T3 Standard Calibrators Abbott AxSYM® Total T3 Master Calibrators

Indications For Use:

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.

Abbott AxSYM Estradiol Standard Calibrators and AxSYM Estradiol Master Calibrators are devices intended for use in the AxSYM 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.

Abbott ARCHITECT FSH Calibrators are devices intended for use in the ARCHITECT FSH assay test system to establish points of reference that are used in the quantitative determination of follicle-stimulating hormone (FSH) in human specimens. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal discorders

ARCHITECT LH Calibrators are devices intended for use in the ARCHITECT LH assay test system to establish points of reference 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.

ARCHITECT Progesterone Calibrators are devices intended for use in the ARCHITECT Progesterone assay test system to establish points of reference 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.

Immunoassay/Clinical Chemistry Calibrator 510(k)

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ARCHITECT Prolactin Calibrators are devices intended for use in the ARCHITECT Prolactin assay test system to establish points of reference 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

AxSYM Total T3 Standard Calibrators and AxSYM Total T3 Master Calibrators are devices intended for use in the AxSYM Total T3 assay test system to establish points of reference that are used in the quantitative determination of total T3 in human specimens. Total T3 measurements are used in the diagnosis and treatment of thyroid disease.

(Please Do Not Write Below This Line. Continue on Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Carol C. Benson for Jean Cooper, DVM
**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032458

Immunoassay/Clinical Chemistry Calibrator 510(k)

September 2003