(35 days)
The Iron assay is used for the quantitation of iron in human serum. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.
Iron is an in vitro diagnostic assay for the quantitative determination of iron in human serum. The Iron assay is a clinical chemistry assay which utilizes an acidic media to release ferric iron from the transferrin. The ferric iron is converted to the ferrous form by the action of hydroxylamine hydrochloride. The released ferrous iron reacts with FERENE® to produce a colored Iron-FERENE complex. The absorbance of the Iron-FERENE complex is measured at 600 nm and is proportional to the concentration of iron present in the sample. Thiourea and detergent are added to reduce copper interference and turbidity, respectively.
The provided text describes a 510(k) submission for an in vitro diagnostic assay called "Iron." The purpose of the submission is to demonstrate substantial equivalence to a predicate device, not to establish new acceptance criteria or conduct a multi-reader multi-case (MRMC) study. The information provided is characteristic of a clinical chemistry assay, which focuses on analytical performance rather than diagnostic accuracy involving human readers.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a table format. Instead, it presents performance characteristics and asserts substantial equivalence to a predicate device. The primary performance metrics are correlation with the predicate, precision, linearity, and limit of quantitation.
| Performance Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Correlation Coefficient | Expected to be high (close to 1) | 0.9938 |
| Slope | Expected to be close to 1 | 0.973 |
| Y-intercept | Expected to be close to 0 | -2.592 ug/dL |
| Within-run Precision | Expected to be low %CV | Level 1: 0.7% (total %CV) |
| Level 2: 1.7% (total %CV) | ||
| Linearity | Sufficiently wide range to cover clinical needs | Up to 1778.5 ug/dL |
| Limit of Quantitation (Sensitivity) | Sufficiently low to detect clinically relevant concentrations | 3.8 ug/dL |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "comparative performance studies" and "precision studies" but does not specify the sample size for these studies.
The data provenance is not explicitly stated regarding country of origin. The studies appear to be retrospective as they are comparing the new assay to an existing, established predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not applicable and therefore not provided in the document. For a clinical chemistry assay like this, "ground truth" is typically established by the reference method (the predicate device) or by established analytical standards, not by human expert consensus or interpretation of test results.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided in the document. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation (e.g., radiology for image-based diagnostics) to resolve discrepancies among multiple expert readers. This is not relevant for a quantitative chemical assay.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study focuses on the impact of a device on human reader performance, typically for diagnostic imaging or similar interpretation tasks. The Iron assay is an in vitro diagnostic for quantitative determination, not an interpretive tool for human readers. Therefore, the effect size of how much human readers improve with AI vs. without AI assistance is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, in essence, the entire performance evaluation of the Iron assay is a standalone performance assessment. Clinical chemistry assays are designed to operate independently and provide a quantitative result. The performance characteristics (correlation, precision, linearity, sensitivity) described are the standalone performance of the assay itself, without human interpretation as part of the primary output.
7. The Type of Ground Truth Used:
For the comparative performance studies, the ground truth was the results obtained from the Boehringer Mannheim® Iron assay on the Hitachi® 717 Analyzer (K854298), which served as the reference or predicate method. For precision, linearity, and sensitivity, the ground truth would be based on known concentrations in control materials or spiked samples.
8. The Sample Size for the Training Set:
This information is not provided and is generally not applicable in the context of this device. Clinical chemistry assays like the Iron assay are typically developed and validated using well-established chemical principles and analytical methodologies. While there's an optimization process during development that might involve testing numerous samples, the concept of a "training set" in the machine learning sense (where an algorithm learns from labeled data) is not relevant to this type of device.
9. How the Ground Truth for the Training Set Was Established:
As noted above, the concept of a "training set" with established ground truth, as understood in machine learning/AI, is not applicable to this clinical chemistry assay. The performance is assessed against established analytical methods and standards.
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510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-6062 Fax (972) 753-3367
| Date of Preparation of this Summary: | May 1, 1998 |
|---|---|
| Device Trade or Proprietary Name: | Iron |
| Device Common/Usual Name or Classification Name: | Iron |
| Classification Number/Class: | 75CFM/Class I |
This summary of 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:
Test Description:
Iron is an in vitro diagnostic assay for the quantitative determination of iron in human serum. The Iron assay is a clinical chemistry assay which utilizes an acidic media to release ferric iron from the transferrin. The ferric iron is converted to the ferrous form by the action of hydroxylamine hydrochloride. The released ferrous iron reacts with FERENE® to produce a colored Iron-FERENE complex. The absorbance of the Iron-FERENE complex is measured at 600 nm and is proportional to the concentration of iron present in the sample. Thiourea and detergent are added to reduce copper interference and turbidity, respectively.
Substantial Equivalence:
The Iron assay is substantially equivalent to the Boehringer Mannheim® Iron assay on the Hitachi® 717 Analyzer (K854298).
Iron 510(k) May 1, 1998 Ironf.lwp
Section II Page 1
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Both assay yield similar Performance Characteristics.
Similarities:
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of iron. .
- Both assays vield similar clinical results. .
Differences:
- There is a difference between the assay range. .
Intended Use:
The Iron assay is used for the quantitation of iron in human serum.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The Iron assay method comparison yielded acceptable correlation with the Boehringer Mannheim Iron assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9938, slope = 0.973, and Y-intercept = - 2.592 ug/dL. Precision studies were conducted using the Iron assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 is 0.7% and Level 2/Panel 102 is 1.7%. The Iron assay is linear up to 1778.5 ug/dL. The limit of quantitation (sensitivity) of the Iron assay is 3.8 ug/dL. These data demonstrate that the performance of the Iron assay is substantially equivalent to the performance of the Boehringer Mannheim Iron assay on the Hitachi 717 Analyzer.
Conclusion:
The Iron assay is substantially equivalent to the Boehringer Mannheim Iron assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
Iron 510(k) May 1, 1998 Section II Page 2
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 8 1998
Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Re : K981581 IRON I Regulatory Class: Product Code: CFM Dated: May 1, 1998 Received: May 4, 1998
Dear Mr. Littlefield:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note --the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Iron Device Name:
Indications For Use:
The Iron assay is used for the quantitation of iron in human serum. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. k 981381
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use OR Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 862.1410 Iron (non-heme) test system.
(a)
Identification. An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.(b)
Classification. Class I (general 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.