(57 days)
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No
The document describes quality control materials and calibrators for immunoassay test systems, which are standard laboratory reagents and do not inherently incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as controls and calibrators used for estimating test precision and detecting analytical deviations in the quantitative determination of substances, which are for diagnostic purposes rather than therapeutic intervention.
No
This device is described as a "control" or "calibrator," which means it is used to ensure the accuracy and precision of a diagnostic assay system, rather than directly performing a diagnosis itself. The text explicitly states their purpose is "to estimate test precision and to detect systematic analytical deviations" or "to establish points of reference," which supports quality control functions rather than diagnostic ones.
No
The device description clearly states that these are "Quality Control Materials" and "Calibrators," which are physical substances used in laboratory testing, not software.
Yes, these devices are In Vitro Diagnostics (IVDs).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that these devices are "intended for use in the ARCHITECT®, AxSYM®, and IMx assay test systems to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of [various hormones] in human specimens." This clearly indicates that the devices are used in vitro (outside the body) to analyze human specimens.
- Device Description: The "Device Description" further reinforces this by stating they 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." and "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 confirms their use in laboratory settings for analyzing human samples.
- Purpose: The purpose of these devices (controls and calibrators) is to ensure the accuracy and reliability of the assay test systems used to measure substances in human specimens. This is a fundamental function of IVDs.
Therefore, based on the provided text, these Abbott devices are designed and intended for use in laboratory settings to perform tests on human specimens, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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
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.
Product codes (comma separated list FDA assigned to the subject device)
JJX, JIT
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
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 (847) 938-4807 Fax (847) 937-9616
Date of Preparation of 510(k) Summary: June 21, 2004
Trade Name(s):
| Trade Name | Common
Name | Device
Classification | Classification
Panel | Product
Code | Regulation
Number |
|---------------------------------------------------------|-----------------------------------------------|--------------------------|-------------------------------|-----------------|----------------------|
| Abbott
ARCHITECT®
Estradiol Controls
(LN 6C22) | Single
Analyte QC
Material
(assayed) | Class I | Clinical
Chemistry
(75) | JJX | 862.1660 |
| Abbott
ARCHITECT®
Estradiol Controls
(LN 2K25) | Single
Analyte QC
Material
(assayed) | Class I | Clinical
Chemistry
(75) | JJX | 862.1660 |
| Abbott AxSYM®
Estradiol Controls | Single
Analyte QC
Material
(assayed) | Class I | Clinical
Chemistry
(75) | JJX | 862.1660 |
| Abbott FSH Controls | Single
Analyte QC
Material
(assayed) | Class I | Clinical
Chemistry
(75) | JJX | 862.1660 |
| Abbott
ARCHITECT® LH
Controls | Single
Analyte QC
Material
(assayed) | Class I | Clinical
Chemistry
(75) | JJX | 862.1660 |
1
| Trade Name | Common
Name | Device
Classification | Classification
Panel | Product
Code | Regulation
Number |
|--------------------------------------------------|-----------------------------------------------|--------------------------|-------------------------------|-----------------|----------------------|
| Abbott
ARCHITECT®
Prolactin Controls | Single
Analyte QC
Material
(assayed) | Class I | Clinical
Chemistry
(75) | JJX | 862.1660 |
| Abbott
ARCHITECT®
Progesterone
Controls | Single
Analyte QC
Material
(assayed) | Class I | Clinical
Chemistry
(75) | JJX | 862.1660 |
| Abbott
ARCHITECT®
Estradiol Calibrators | Calibrator | Class II | Clinical
Chemistry
(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.
2
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).
3
Page 2
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 (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,
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
4
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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5
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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