(56 days)
An Abbott Clinical Chemistry 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.
Abbott Clinical Chemistry Calibrators were used for the calibration of each clinical chemistry reagent on the ALCYON 300/300i. The calibration curve generated was used for the quantitation of each analyte for the purpose of collecting performance data in support of the reagent 510(k) as outlined on the next page.
The provided text describes the submission of a 510(k) for Abbott Clinical Chemistry Calibrators. These are in vitro diagnostic devices intended for use in clinical chemistry assays to establish points of reference for the measurement of substances in human specimens.
However, the document does not contain a detailed study proving the device meets specific acceptance criteria in the way described in your request for AI/medical imaging devices. This is because calibrators, unlike diagnostic algorithms, are typically evaluated through different validation processes.
Here's an breakdown based on the information available and why certain sections of your request cannot be fulfilled:
Acceptance Criteria and Device Performance (Based on provided text)
| Criterion | Reported Device Performance |
|---|---|
| Intended Use Fulfillment | The calibrators (Amm Cal, Bil Cal, CO2 Cal, HDL Cal, Iron/Mg Cal, LDL Cal, MC Cal, UPro Cal, and ISE Calibrator Levels 1 and 2) are intended for in vitro diagnostic use in specific clinical chemistry assays (e.g., Ammonia, Bilirubin, Carbon Dioxide, HDL, Iron, Magnesium, LDL, etc.). |
| Calibration Curve Generation | Abbott Clinical Chemistry Calibrators were used for the calibration of each clinical chemistry reagent on the ALCYON 300/300i. The calibration curve generated was used for the quantitation of each analyte for the purpose of collecting performance data in support of the reagent 510(k). |
| Substantial Equivalence (Regulatory) | The FDA determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use (K981706). |
| Compliance with General Controls | The device is subject to general controls provisions of the Act (annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration). |
| Compliance with QS Regulation (GMP) | A substantially equivalent determination assumes compliance with Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices (21 CFR Part 820). |
Study Information (Based on provided text)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document describes the calibrators' intended use in supporting the performance data for reagents, rather than a direct study on the calibrators themselves with a test set of human specimens. The 510(k) process for calibrators often focuses on their stability, traceability, and ability to produce expected values when used with their respective reagents, which involves different types of testing.
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)
- Not applicable/Not provided. This type of information is relevant for AI algorithms that diagnose or interpret medical images. For a calibrator, "ground truth" would relate to the accuracy and traceability of the calibrator's assigned values, which is typically established through metrological methods, reference materials, and laboratory testing, not expert consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Pertains to expert review of discrepancies in AI performance evaluation.
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
- Not applicable/Not provided. Pertains to AI diagnostic algorithms.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not provided. Pertains to AI diagnostic algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly detailed in the document. For calibrators, "ground truth" refers to the highly accurate and traceable assigned values for each analyte within the calibrator. This is established through rigorous laboratory methods, often traceable to international reference materials or definitive methods (e.g., mass spectrometry for small molecules). The document states the calibrators generate curves for "quantitation of each analyte," implying their values serve as the reference.
8. The sample size for the training set
- Not applicable/Not provided. This refers to machine learning models.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This refers to machine learning models.
Summary regarding the nature of this submission:
This 510(k) submission is for calibrators, which are reference materials used to ensure the accuracy of other diagnostic tests (reagents). The "study" referenced in the text is not a clinical trial or an AI performance study with patient data, but rather the internal validation demonstrating that these calibrators can successfully generate "calibration curves" for specific reagents on a particular instrument (ALCYON 300/300i). The performance data collected using these calibrators would then be submitted as part of the 510(k) for the individual reagents themselves (as indicated by the list of K numbers for each reagent).
Therefore, the type of detailed performance evaluation requested, particularly concerning expert review and AI-specific metrics, is not present because it's not relevant for this type of in vitro diagnostic calibrator.
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9 1998 JUL
510(k) Summary
| Submitter's Name/Address | Abbott Laboratories |
|---|---|
| 1920 Hurd Drive | |
| Irving, Texas 75038 | |
| Contact Person | Mark Littlefield |
| Section Manager MS 1-8 | |
| ADD Regulatory Affairs | |
| (972) 518-6062 | |
| Fax (972) 753-3367 |
| Date of Preparation of this Summary: | May 13, 1998 |
|---|---|
| Device Trade or Proprietary Name: | Amm Cal, Bil Cal, CO2 Cal,HDL Cal, Iron/Mg Cal, LDL Cal,MC Cal, UPro Cal, and ISECalibrator Levels 1 and 2. |
Device Common/Usual Name or Classification Name: Abbott Clinical Chemistry Calibrators
Classification Number/Class: Class II
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: _______________________________________________________________________________________________________________________________________________
Intended Use:
The Ammonia Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for Ammonia.
The Bilirubin Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for Bilirubin.
The Carbon Dioxide Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for Carbon Dioxide.
The HDL Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for HDL.
Abbott Calibrators 510(k) May 13, 1998 Calibrator 510k.lwp
Section I Page 1
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The Iron/Magnesium Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for Iron and Magnesium.
The LDL Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for LDL.
The MC Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for Albumin, Calcium, Cholesterol, Creatinine, Glucose, Phosphorus, Total Protein, Triglyceride, Urea Nitrogen, and Uric Acid.
The UPro Calibrator is intended for in vitro diagnostic use in clinical chemistry assays for protein in urine and CSF.
The ISE Calibrator Levels 1 and 2 are intended for in vitro diagnostic use in clinical chemistry assays for Sodium, Potassium, and Chloride.
Conclusion: Abbott Clinical Chemistry Calibrators were used for the calibration of each clinical chemistry reagent on the ALCYON 300/300i. The calibration curve generated was used for the quantitation of each analyte for the purpose of collecting performance data in support of the reagent 510(k) as outlined on the next page.
bbott Calibrators 510(k) May 13, 1998 Calibrator Sick lwo
Section I Page 2
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| Calibrator Name | Reagent Name | Reagent 510(k)Number |
|---|---|---|
| Ammonia Calibrator | Ammonia | K981467 |
| Liquid Bilirubin Calibrator | Total Bilirubin | K981336 |
| Direct Bilirubin | K981222 | |
| Carbon Dioxide Calibrator | Carbon Dioxide | K981231 |
| HDL Calibrator | Direct HDL | K981224 |
| Iron/MagnesiumCalibrator | Iron | K981241 |
| Magnesium | K981192 | |
| LDL Calibrator | Direct LDL | K981303 |
| ISE Calibrator Levels Iand Level 2 | SodiumPotassiumChloride | K974779 |
| MulticonstituentCalibrator | Albumin BCG | K981468 |
| Albumin BCP | K981457 | |
| Calcium | K981232 | |
| Cholesterol | K981476 | |
| Creatinine | K981240 | |
| Glucose | K981185 | |
| Phosphorus | K981118 | |
| Total Protein | Exempt Class II | |
| Triglyceride | K981223 (Exempt Class I) | |
| Urea Nitrogen | K981123 | |
| Uric Acid | K981189 | |
| Urine/CSF ProteinCalibrator | Urine/CSF Protein | K981295 |
Section I
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 0 1098
Mark Littlefield . Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Re : K981706 Amm Cal, Bil Cal, CO2 Cal, HDL Cal, Iron/Mg Cal, LDL Cal, MC Cal, Upro Cal, and ISE Calibrator Levels 1 and 2 Regulatory Class: II Product Code: JIX Dated: May 13, 1998 Received: May 14, 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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 Requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: 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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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 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 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 "dsmo@fdadr.cdrh.fda.qov".
Sincerely yours,
Steven Autman
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
Page 2
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510(k) Number (if known):
Device Name: _ Abbott Clinical Chemistry Calibrators
Indications For Use:
An Abbott Clinical Chemistry 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.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K981706
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use i (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.