K Number

Device Name

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

Manufacturer

ABBOTT LABORATORIES

Date Cleared

2003-10-06

(56 days)

Product Code

JIT

Regulation Number

862.1150

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 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.

More Information

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Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K951629, K890135, K935611, K955025, K896162, K934517

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes calibrators for immunoassay and clinical chemistry systems, which are used to establish reference points for quantitative measurements. There is no mention of AI or ML in the intended use, device description, or any other section. The function described is a standard calibration process, not one that would typically involve AI/ML.

Therapeutic

No
The device is a calibrator used in diagnostic assay systems to establish reference points for quantitative determination, not for direct therapeutic use.

Diagnostic

The device description clearly states "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." This indicates they are calibrators for diagnostic tests, not diagnostic devices themselves.

SaMD (Software as a Medical Device)

The device description clearly states that these are "Abbott Immunoassay/Clinical Chemistry Calibrators," which are physical substances used to calibrate laboratory instruments. This is not a software-only device.

IVD (In Vitro Diagnostic)

Yes, based on the provided text, these devices are IVDs (In Vitro Diagnostics).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that these devices are "intended for use in the [specific Abbott assay] test system to establish points of reference that are used in the quantitative determination of [specific substance] in human specimens." This clearly indicates they are used to analyze human specimens in vitro (outside the body).
Purpose: The purpose is to "establish points of reference" for quantitative determination, which is a fundamental function of calibrators in diagnostic testing.
Clinical Application: The text also describes how the measurements obtained using these calibrators are "used in the diagnosis and treatment of various hormonal sexual disorders," "assessing placental function," "diagnosis and treatment of pituitary gland and gonadal disorders," "diagnosis and treatment of gonadal function," "diagnosis and treatment of disorders of the ovaries or placenta," "diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain," and "diagnosis and treatment of thyroid disease." These are all clinical applications for diagnostic purposes.
Device Description: The "Device Description" further reinforces this by stating they 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."

The combination of analyzing human specimens in vitro for the purpose of diagnosis and treatment clearly aligns with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

JIT

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K951629, K890135, K935611, K955025, K896162, K934517

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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,

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

11:00 PM

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.

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

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)

(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