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 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.

AI/ML Overview

The provided text is a 510(k) summary for Immunoassay/Clinical Chemistry Calibrators, which are in vitro diagnostic devices. It focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through a clinical study for a standalone medical device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, effect size, standalone performance, ground truth for training set) are not applicable to this type of submission.

However, I can extract the relevant information regarding the device's characteristics and the basis for its acceptance by the FDA (i.e., substantial equivalence).

Here's a summary tailored to the provided document:

Acceptance Criteria and Study Information for Abbott Immunoassay/Clinical Chemistry Calibrators (K032458)

The acceptance criteria for these devices are based on demonstrating "substantial equivalence" to legally marketed predicate devices, as guided by the FDA Guidance for Industry "Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators" issued February 22, 1999. This means the new devices (calibrators) must be as safe and effective as existing legally marketed calibrators.

The "study" or justification proving the device meets these criteria is a comparison to predicate devices, detailing similarities and differences, and asserting that any differences do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For calibrators, "performance" is generally demonstrated by their intended function of establishing reference points for quantitative assays and their chemical composition, rather than clinical efficacy metrics typical of a therapeutic device. The "Acceptance Criteria" here are derived from the similarities and the claim of substantial equivalence to the predicate.

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (Characteristics of Subject Device)
Intended Use: Establish points of reference for quantitative determination of substances in human specimens.	Each calibrator is designed "for use in [specific assay] test system to establish points of reference that are used in the quantitative determination of [analyte] in human specimens."
Analyte Detection: For use with quantitative immunoassays detecting specific analytes (e.g., Estradiol, FSH, LH, Progesterone, Prolactin, Total T3).	Each calibrator is specifically named for its analyte (e.g., "Abbott ARCHITECT® Estradiol Calibrators") and explicitly states its intended use for quantitative determination of that analyte.
Matrix/Composition: Similar buffer or serum bases.	ARCHITECT Estradiol: Tris Buffer based. AxSYM Estradiol: Tris Buffer based. ARCHITECT FSH: Bovine serum based. ARCHITECT LH: Calf serum based. ARCHITECT Progesterone: Human serum based. ARCHITECT Prolactin: Tris buffer based. AxSYM Total T3: Bovine serum based.
Standardization/Traceability: Referenced to internal standards and/or international reference preparations.	Estradiol Calibrators: Standardized to internal reference standards (purity no less than 97% by HPLC for ARCHITECT; correlated with GCMS for AxSYM). FSH Calibrators: Referenced against WHO FSH 2nd IRP 78/549. LH Calibrators: Referenced to WHO Luteinizing Hormone (LH) Human, Pituitary 2nd IRP 80/552. Prolactin Calibrators: Referenced to WHO 3rd International Standard 84/500 for Prolactin. Total T3 Calibrators: Signal matched to Abbott internal reference standards, traceable to USP Reference Standard L-Triiodothyronine (free acid), concentration by HPLC.
Number of Levels: May vary but must be appropriate for establishing reference points.	ARCHITECT Estradiol, FSH, LH, Progesterone, Prolactin: 2 levels. AxSYM Estradiol Standard: 6 levels. AxSYM Estradiol Master: 2 levels. AxSYM Total T3 Standard: 6 levels. AxSYM Total T3 Master: 2 levels.

2. Sample Size and Data Provenance for Test Set

Sample Size: Not applicable. This submission does not involve a clinical "test set" in the traditional sense of patient samples for diagnostic performance evaluation. The "test" environment is the internal laboratory validation of the calibrator's chemical and functional properties.
Data Provenance: Not applicable for patient data. The "data" provided is comparison data between the new calibrators and existing predicate calibrators, focusing on their chemical formulation, standardization, and intended use. This is internal company data.

3. Number and Qualifications of Experts for Ground Truth

Number of Experts: Not applicable. Ground truth for a calibrator usually refers to the accuracy of the concentration values assigned to the calibrator levels, which is established through rigorous chemical and analytical methods, often traceable to international standards. It's not typically determined by human expert consensus on clinical cases.
Qualifications of Experts: The experts involved would be analytical chemists and metrologists within Abbott Laboratories responsible for manufacturing, quality control, and standardization, ensuring accuracy and traceability.

4. Adjudication Method

Adjudication Method: Not applicable. There is no adjudication required for this type of submission as there are no independent expert readings of cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This type of study is not relevant for an in vitro diagnostic calibrator.

6. Standalone Performance Study (Algorithm Only)

Standalone Performance Study: Not applicable. These are physical calibrator products, not algorithms. Their performance is validated through their ability to correctly calibrate an assay system, rather than standalone diagnostic accuracy.

7. Type of Ground Truth Used

Ground Truth: The "ground truth" for calibrators is the assigned concentration value for each calibrator level, established through:
- Traceability to International Reference Standards: E.g., WHO International Reference Preparations for hormones.
- Analytical Methods: E.g., HPLC (High-Performance Liquid Chromatography) and Gas Chromatography/Mass Spectrometry (GCMS) for purity and concentration determination.
- Gravimetric Preparation: Manufacturing calibrators by precisely weighing highly pure substances.
- Internal Reference Standards: Carefully characterized and stable internal standards used for signal matching and calibration.

8. Sample Size for the Training Set

Sample Size: Not applicable. There is no "training set" in the context of an AI/ML algorithm for these calibrator products. The calibrators themselves are "trained" or standardized through a manufacturing and quality control process using the ground truth methods mentioned above.

9. How the Ground Truth for the Training Set was Established

Ground Truth Establishment: As explained in point 7, the "ground truth" (assigned values for calibrator levels) is established through:
- Referencing international standards (WHO, USP).
- Analytical techniques (HPLC, GCMS) to determine purity and concentration of raw materials.
- Gravimetric preparation.
- Standardization against well-characterized internal reference standards.

Summary

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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
	(847) 938-5032
	Fax (847) 937-9616
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:

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 NameARCHITECT EstradiolCalibrators	Predicate DeviceIMx Estradiol Calibrators(K951629)	SimilaritiesBoth are calibrators intended to establish●points of reference.Both are for use with quantitativeimmunoassays which detect EstradiolBoth are Tris Buffer based.●Both are standardized to an internalreference standards using Estradiol(purity no less than 97% by HPLC).	IMx Estadiol Calibrators contain6 levels (0, 50, 250, 750, 1500,3000 pg/mL) intended toestablish points of reference.ARCHITECT Estradiol●Calibrators contain 2 levels (0,1600 pg/mL).
AxSYM Estradiol StandardCalibratorsAxSYM Estradiol MasterCalibrators	IMx Estradiol Calibrators(K951629)	Both are calibrators intended to establishpoints of reference.Both are for use with quantitativeimmunoassays which detect EstradiolBoth are Tris Buffer based.●Both contain 6 levels that are intended to●establish points of reference.	IMx Estradiol Calibrators arestandardized to an internalreference standards usingEstradiol (purity no less than97% by HPLC).AxSYM Estradiol Calibrators arestandardized to an internalreference standard for AxSYMEstradiol. These internalstandards are standardized tocorrelate with gaschromatography/massspectrometry (GCMS).IMx Estadiol Calibrators contain6 levels at (0, 50, 250, 750, 1500,3000 pg/mL) intended toestablish points of reference.AxSYM Estradiol StandardCalibrators contain 6 levels (0,50, 100, 200, 500, 1000 pg/mL)intended to establish points ofreference.AxSYM Estradiol Master●Calibrators contain 2 levels (0,200 pg/mL) intended to establishpoints of reference.
ARCHITECT FSHCalibrators	Abbott FSH Calibrators(K890135)	Both are calibrators intended to establish●points of reference.Both are for use with quantitative●immunoassays, which detect FSH.Both are Bovine serum based.Both sets of calibrators are manufacturedby addition of Follicle StimulatingHormone (FSH) of known concentrationto obtain a target concentration. Theconcentration is referenced against WorldHealth Organization (WHO) FSH 2ndInternational Reference Preparation (IRP)78/549.	ARCHITECT FSH Calibratorscontain 2 levels (0, 100 mIU/mL)intended to establish points ofreference.Abbott FSH Calibrators contain●6 levels (0, 1, 10, 50, 100, 150mIU/mL).
ARCHITECT LHCalibrators	AxSYM LH StandardCalibrators (K935611)	Both are calibrators intended to establishpoints of reference.Both are for use with quantitativeimmunoassays, which detect LH.Both are calf serum based.●Both sets are of calibrators are●manufactured gravimetrically andreferenced to the World HealthOrganization (WHO) LuteinizingHormone (LH) Human, Pituitarv 2nd	ARCHITECT LH Calibratorscontain 2 levels (2, 100 mIU/mL)intended to establish points ofreference.AxSYM LH Calibrators contain●6 levels (0, 2, 10, 25, 100, 250mIU/mL).
Calibrator Name	Predicate Device	Similarities	Differences
ARCHITECT ProgesteroneCalibrators	AxSYM Progesterone StandardCalibrators (K955025)	International Standard 80/552 at eachconcentration.● Both are calibrators intended to establishpoints of reference.● Both are for use with quantitativeimmunoassays, which detectProgesterone.	● The ARCHITECT ProgesteroneCalibrators contain 2 levels (0.7,40.0 ng/mL).● The AxSYM ProgesteroneStandard Calibrators contain 6levels (0, 0.7, 2, 7, 20, 40ng/mL).● The ARCHITECT ProgesteroneCalibrators are human serumbased.● The AxSYM ProgesteroneStandard Calibrators are serumbased for Level 0 and Tris bufferbased for the remaining levels.
ARCHITECTProlactinCalibrators	Abbott Prolactin Calibrators(K896162)	● Both are calibrators intended to establishpoints of reference.● Both are for use with quantitativeimmunoassays which detect Prolactin.● Both are referenced to the World HealthOrganization (WHO) 3rd InternationalStandard 84/500 for Prolactin at eachconcentration level.● Both are Tris buffer based.	● The ARCHITECT ProlactinCalibrators contain 2 levels (5,30 ng/mL).● The Abbott Prolactin Calibratorscontain 6 levels (0, 5, 10, 30, 80,200 ng/mL).
AxSYM Total T3 StandardCalibrators (LN 7A52-02)AxSYM Total T3 MasterCalibrators (LN 7A52-32)which are Calibrators A andC of the StandardCalibrators	AxSYM Total T3 StandardCalibrators (K934517)AxSYM Total T3 MasterCalibrators which areCalibrators A and C of theStandard Calibrators(K934517)	● Both are calibrators intended to establishpoints of reference.● Both are for use with quantitativeimmunoassays, which detect Total T3.● Both contain 6 levels (0, 0.5, 1, 2, 4, 8ng/mL) for the Standard Calibrators and2 levels (0, 1 ng/mL) for the MasterCalibrators.● Both are bovine serum based.	● AxSYM Total T3 StandardCalibrators LN 7A52-02 andAxSYM Total T3 MasterCalibrators 7A52-32 aremanufactured using L-Triiodothyronine, sodium salt,(USP Grade) and signal matchedto Abbott internal referencestandards which are traceable tothe USP Reference Standard L-Triiodothyronine (free acid) ateach concentration level. Theconcentration of the T3 stocksolution used to make theinternal reference standards isdetermined by HPLC.● AxSYM Total T3 StandardCalibrators and AxSYM TotalT3 Master Calibrators (K934517)are standardized as follows:Abbott manufactures internalreference standards for Total T3using L-TriiodothryonineSodium (HPLC purity 95.0-101.0%). Total T3 primary andsecondary calibrators aremanufactured gravimetricallyutilizing this internal referencestandard. All list material istested against these primary andsecondary calibrators.

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11:00 PM

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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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Page 2 -

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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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:

Immunoassay/Clinical Chemistry Calibrator 510(k)

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(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)

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

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
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.)(b)
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.