The ARCHITECT LH Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of human luteinizing hormone (LH) in human serum and plasma.

Device Description

The ARCHITECT LH Calibrator kit contains 6 bottles (4.0 mL each) of ARCHITECT LH Calibrators A, B, C, D, E, and F. Calibrators A through F contain phosphate buffer with protein (bovine) stabilizers. Calibrators B through F also contain different concentration levels of luteinizing hormone (from human pituitary). Preservatives: ProClin 300, ProClin 950.

AI/ML Overview

This submission is for a medical device called "ARCHITECT LH Calibrators," which is a secondary calibrator for quantitative determination of human luteinizing hormone (LH). This type of device does not typically undergo the same kind of "performance studies" as an in-vitro diagnostic test that directly measures a biological marker or an AI-powered diagnostic tool. Instead, the "acceptance criteria" and "study" for a calibrator largely revolve around demonstrating its ability to accurately and precisely calibrate the instrument it's intended for, and that it is substantially equivalent to a previously approved device.

Based on the provided information, the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense (e.g., sensitivity, specificity for disease detection).

Here's an interpretation of "acceptance criteria" and "device performance" based on the provided document, even though it's structured as a comparison for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of "acceptance criteria" against clinical metrics, the acceptance is based on demonstrating equivalency to a predicate device. The "performance" here refers to the characteristics and specifications of the new calibrator relative to the predicate.

Attribute	"Acceptance Criteria" (Predicate Device Specification)	Reported Device Performance (New Device Specification)
Intended Use	For calibration of ARCHITECT i System for quantitative determination of LH in human serum and plasma.	Same
Instrumentation	ARCHITECT i System	Same
Range	2 mIU/mL – 100 mIU/mL	0.00 mIU/mL – 250.00 mIU/mL
LH Calibrator Levels	2 levels (2 and 100 mIU/mL)	6 levels (0.00, 1.00, 3.50, 15.00, 50.00, 250.00 mIU/mL)
Calibrator Matching	Calibrators must be used with matched reagents and controls per labeling.	Matching of calibrators with reagents and controls is not required.
Composition (LH Source)	Luteinizing hormone (from human pituitary)	Luteinizing hormone (from human pituitary) - changed vendor code
Composition (Diluent)	Calf serum	Phosphate buffer with protein stabilizers (bovine)
Composition (Preservative)	Sodium Azide	ProClin 300, ProClin 950
Standardization	Referenced to WHO LH Human, Pituitary 2nd International Standard 80/552 at each concentration.	Referenced to WHO LH Human, Pituitary 2nd International Standard 80/552. Note: Calibrators B-F are manufactured by dilution.

Interpretation of "Acceptance": The "acceptance" (or determination of substantial equivalence by the FDA) is based on the argument that despite differences (e.g., expanded range, more calibrator levels, different diluent/preservatives), the fundamental principles of the calibrator, its intended use, and its traceability to an international standard remain consistent with a legally marketed predicate device, and these differences do not raise new questions of safety or effectiveness. The FDA's letter states: "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..."

Since this is a calibrator and the submission is focused on substantial equivalence rather than a new diagnostic claim, many of the typical performance study questions for AI/diagnostic devices are not directly applicable. However, I will address them based on the context of the provided document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given 510(k) summary. For a calibrator, the "test set" would typically refer to the experiments conducted to validate its performance (e.g., accuracy, precision, linearity within the specified range) on the intended instrument. This kind of detailed study data is usually included in the full 510(k) submission but summarized only at a high level or by reference in the public summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable and not provided. Calibrators are characterized chemically and biologically; their "ground truth" is established through analytical validation processes against recognized standards (like the WHO standard mentioned), not by expert consensus on clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable and not provided. Adjudication methods are relevant for subjective interpretations (e.g., image reading) where disagreement among experts needs resolution to establish ground truth.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., radiologists, pathologists) often assisted by AI. This device is a calibrator, not a diagnostic tool or an AI algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This device is a biochemical calibrator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the calibrators themselves is established by referencing them to the World Health Organization (WHO) Luteinizing Hormone (LH) Human, Pituitary 2nd International Standard 80/552. This is a highly standardized biological standard used to ensure comparability and accuracy of LH measurements worldwide. The concentrations of LH in the calibrators are derived from this international standard.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" in the context of a calibrator for an immunoassay system. This concept is relevant for machine learning or AI algorithms.

9. How the ground truth for the training set was established

This is not applicable. As stated above, there is no "training set" for this type of device.

Summary

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510(k) Summary (Summary of Safety and Effectiveness)

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K111023.

Applicant Name:

John Rizos, Senior Regulatory Affairs Administrator Regulatory Affairs Abbott Laboratories Diagnostics Division Dept. 9V6, AP5N-2 100 Abbott Park Road Abbott Park, IL 60064 john.rizos@abbott.com

Device Name:

Classification Name: Calibrator, Secondary Trade Name: ARCHITECT LH Calibrators Common Name: Human Luteinizing Hormone Governing Regulation: 862.1150 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: JIT

Legally marketed device to which equivalency is claimed:

Abbott ARCHITECT LH Calibrators (List No. 7G94-01), K032458

Intended Use of Device:

The ARCHITECT LH Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of human luteinizing hormone (LH) in human serum and plasma.

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Description of Device:

Comparison Table:

and the same of the same of the same of the same

The table below compares the new device, ARCHITECT LH Calibrators, List No. 2P40-01, with the predicate device, ARCHITECT LH Calibrators, List No. 7G94-01 (K032458).

Comparison of New Device to Predicate Device
Attribute	Predicate DeviceARCHITECT LH CalibratorsList No. 7G94-01, K032458	New DeviceARCHITECT LH CalibratorsList No. 2P40-01
Intended Use	For the calibration of theARCHITECT i System whenused for the quantitativedetermination of humanluteinizing hormone (LH) inhuman serum and plasma.	Same
Instrumentation	ARCHITECT i System	Same
Range	2 mIU/mL – 100 mIU/mL	0.00 mIU/mL – 250.00 mIU/mL
LH Calibrators	• 2 levels• 2 and 100 mIU/mL humanluteinizing hormone• Calibrators must be used withmatched reagents and controlsper labeling.	• 6 levels• 0.00, 1.00, 3.50, 15.00, 50.00,250.00 mIU/mL humanluteinizing hormone• Note: Matching of calibratorswith reagents and controls isnot required.
Composition	• Calibrators 1-2: Luteinizinghormone (from humanpituitary)• Calibrators 1-2: Diluent: Calfserum• Calibrators 1-2: Preservative:Sodium Azide	• Calibrators B-F: Luteinizinghormone (from humanpituitary) - changed vendorcode• Calibrators A-F: Diluent:Phosphate buffer with proteinstabilizers (bovine)• Calibrators A-F: Preservatives:ProClin 300, ProClin 950

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Comparison of New Device to Predicate Device
Attribute	Predicate DeviceARCHITECT LH CalibratorsList No. 7G94-01, K032458	New DeviceARCHITECT LH CalibratorsList No. 2P40-01
Standardization	The calibrators are manufacturedby dilution and referenced to theWorld Health Organization(W.H.O.) Luteinizing Hormone(LH) Human, Pituitary 2ndInternational Standard 80/552 ateach Concentration.	The calibrators are referenced tothe World Health Organization(WHO) Luteinizing Hormone(LH) Human, Pituitary 2ndInternational Standard 80/552.Note: Calibrators B-F aremanufactured by dilution.

Conclusion:

Substantial equivalence for the new device, ARCHITECT LH Calibrators (List No. 2P40-01), is claimed to the predicate device cleared in K032458, ARCHITECT LH Calibrators (List No. 7G94-01), based on the information described above.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized emblem consisting of three abstract shapes resembling birds in flight or flowing lines.

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Abbott Laboratories c/o Mr. John Rizos Senior Regulatory Affairs Administrator 100 Abbott Park Road Department 9V6, AP5N-2 Abbott Park, IL 60064

JUN 1 0 2011

Re: K111023 Trade Name: Architect LH Calibrators Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIT Dated: April 12, 2011 Received: April 19, 2011

Dear Mr. Rizos:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

G.C. L

Courtney Harper, Ph.D. 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): K111023

Device Name: ARCHITECT LH Calibrators

Indications for Use

The ARCHITECT LH Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of human luteinizing hormone (LH) in human serum and plasma.

Prescription Use _X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_(c11/ 02

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.