(58 days)
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No
The document describes calibrators for a laboratory assay, which are chemical reagents used to establish a standard curve. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The description focuses on the chemical composition and intended use for calibration.
No
The device is a calibrator used to ensure the accuracy of the ARCHITECT i System when measuring luteinizing hormone, not for direct therapeutic treatment or diagnosis in patients.
No
Explanation: This device is a calibrator for a system that determines luteinizing hormone levels. It is used to ensure the accuracy of a diagnostic test, but it is not a diagnostic device itself.
No
The device description clearly states it is a kit containing bottles of calibrators, which are physical substances (liquids) used for calibrating a separate system. This is a hardware/reagent device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the calibrators are for the "quantitative determination of human luteinizing hormone (LH) in human serum and plasma." This is a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is a kit containing calibrators used in conjunction with an analytical system (ARCHITECT i System) to measure a substance (LH) in biological fluids (serum and plasma). This is characteristic of an IVD.
- Predicate Device: The presence of a predicate device (K032458; Abbott ARCHITECT LH Calibrators) which is also an IVD, further supports the classification of this device as an IVD.
The information provided clearly indicates that this device is used to perform a diagnostic test on biological samples outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JIT
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.
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.
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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§ 862.1150 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.
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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:
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.
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 Device | |
| ARCHITECT LH Calibrators | ||
| List No. 7G94-01, K032458 | New Device | |
| ARCHITECT LH Calibrators | ||
| List No. 2P40-01 | ||
| Intended Use | For the calibration of the | |
| ARCHITECT i System when | ||
| used for the quantitative | ||
| determination of human | ||
| luteinizing hormone (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 Calibrators | • 2 levels | |
| • 2 and 100 mIU/mL human | ||
| luteinizing hormone | ||
| • Calibrators must be used with | ||
| matched reagents and controls | ||
| per labeling. | • 6 levels | |
| • 0.00, 1.00, 3.50, 15.00, 50.00, | ||
| 250.00 mIU/mL human | ||
| luteinizing hormone | ||
| • Note: Matching of calibrators | ||
| with reagents and controls is | ||
| not required. | ||
| Composition | • Calibrators 1-2: Luteinizing | |
| hormone (from human | ||
| pituitary) | ||
| • Calibrators 1-2: Diluent: Calf | ||
| serum | ||
| • Calibrators 1-2: Preservative: | ||
| Sodium Azide | • Calibrators B-F: Luteinizing | |
| hormone (from human | ||
| pituitary) - changed vendor | ||
| code | ||
| • Calibrators A-F: Diluent: | ||
| Phosphate buffer with protein | ||
| stabilizers (bovine) | ||
| • Calibrators A-F: Preservatives: | ||
| ProClin 300, ProClin 950 |
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| Comparison of New Device to Predicate Device | ||
|---|---|---|
| Attribute | Predicate Device | |
| ARCHITECT LH Calibrators | ||
| List No. 7G94-01, K032458 | New Device | |
| ARCHITECT LH Calibrators | ||
| List No. 2P40-01 | ||
| Standardization | The calibrators are manufactured | |
| by dilution and referenced to the | ||
| World Health Organization | ||
| (W.H.O.) Luteinizing Hormone | ||
| (LH) Human, Pituitary 2nd | ||
| International Standard 80/552 at | ||
| each Concentration. | The calibrators are referenced to | |
| the World Health Organization | ||
| (WHO) Luteinizing Hormone | ||
| (LH) Human, Pituitary 2nd | ||
| International Standard 80/552. | ||
| Note: Calibrators B-F are | ||
| manufactured 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)
C
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_(c11/ 02