(137 days)
The "Wiener lab. Ca-Color Arsenazo III AA" test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of calcium in human sera, heparinized plasmas and urine on both manual and automated systems. Measurements of calcium are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal diseases and tetany (intermittent muscular contractions or spasms).
Calcium reacts with Arsenazo III, yielding a blue colored complex, which is photocolorimetrically measured at 650 nm. 8-hydroxyquinoline is added to remove magnesium interference.
The provided text describes the Wiener Lab. CA-COLOR ARSENAZO III AA test system, a device for quantitative determination of calcium in human sera, heparinized plasmas, and urine. The document is a 510(k) summary, which aims to establish substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, while noting the limitations in the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the new device (CA-COLOR ARSENAZO III AA) with a predicate device (CA-COLOR AA) across several performance characteristics. While direct "acceptance criteria" are not explicitly stated as numerical thresholds for the new device, the comparison to the predicate device serves as the basis for demonstrating substantial equivalence, implying that performance similar to the predicate is acceptable.
| Performance Characteristic | Predicate Device (CA-COLOR AA) Reported Performance | New Device (CA-COLOR ARSENAZO III AA) Reported Performance | Implied Acceptance Criteria (relative to predicate) |
|---|---|---|---|
| Intended Use | Quantitative determination of calcium in human serum, heparinized plasma and urine. | Quantitative determination of calcium in human sera, heparinized plasmas and urine on both manual and automated systems. | Same intended use. |
| Test Principle | Calcium reacts with o-Cresolphtalein complexone (o-CPC) at pH 10.8, yielding a purple colored complex, which is photocolorimetrically measured at 570 nm. 8-hydroxyquinoline is added to remove magnesium interference. | Calcium reacts with Arsenazo III, yielding a blue colored complex, which is photocolorimetrically measured at 650 nm. 8-hydroxyquinoline is added to remove magnesium interference. | Functional principle, though chemical reagents and wavelength differ. |
| Essential Components | o-CPC, 8-hydroxyquinoline | Arsenazo III, 8-hydroxyquinoline | Different main reagent, but same interference eliminator. |
| Reagent Storage | Room temperature | 2 - 10°C | Different, but specified. |
| Reagent Deterioration | Reagent Blank > 0.400 O.D. | Reagent turbidity, Reagent Blank > 0.800 O.D. | Different, but specified. |
| Preparation of Working Reagent | Mixture of R1 and R2 (1:1) or they can be used separately. | None | Simplified. |
| Working Reagent Stability | Stable 4 days at 2-10°C | Same as kit stability | Different, but specified. |
| Precautions | All glassware should be cleaned with diluted hydrochloric acid and rinsed with distilled water. | (Not specified, assumed to be covered by general lab practice or similar to predicate if not mentioned) | (Likely similar or standard lab practice) |
| Working Temperatures | Room temperature - 37°C | (Not specified, assumed to be similar or standard lab practice) | (Likely similar or standard lab practice) |
| Wavelength of Reading | 560 - 590 nm | 620 - 650 nm | Different, but specified. |
| Linearity | 20 mg/dl | (Not explicitly stated for new device, but implied to be acceptable for equivalence) | Implied to be at least 20 mg/dl or comparable. |
| Expected Values | Serum: 8.5-10.5 mg/dl, Urine: 60-200 mg/24hr | (Not explicitly stated for new device, but implied to be acceptable for equivalence) | Implied to be comparable to predicate. |
| Within-run Precision (Normal Level Serum) | CV = 1.28% | CV = 1.93% | Comparable to the predicate (both below 2%). |
| Within-run Precision (High Level Serum) | CV = 1.30% | CV = 0.88% | Comparable to the predicate (both below 2%). Improvement at high level. |
| Within-run Precision (Normal Level Urine) | CV = 1.06% | CV = 2.57% | Comparable, though slightly higher CV for new device at normal urine level. |
| Within-run Precision (High Level Urine) | CV = 0.68% | CV = 1.79% | Comparable, though slightly higher CV for new device at high urine level. |
| Run-to-run Precision (Normal Level Serum) | CV = 1.74% | CV = 1.74% | Identical. |
| Run-to-run Precision (High Level Serum) | CV = 1.70% | CV = 1.29% | Comparable, improvement for the new device. |
| Run-to-run Precision (Normal Level Urine) | CV = 2.50% | CV = 2.44% | Comparable. |
| Run-to-run Precision (High Level Urine) | CV = 1.34% | CV = 2.62% | Comparable, though slightly higher CV for new device at high urine level. |
2. Sample Size Used for the Test Set and Data Provenance
The document provides precision data (Within-run and Run-to-run) for both Normal and High levels in Serum and Urine. However, it does not specify the sample size (number of replicates or samples) used for generating these precision values, nor does it specify the data provenance (country of origin, retrospective or prospective). This information is a significant omission from the provided summary regarding the study details.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this diagnostic device. The "ground truth" for a calcium test system is established by the actual calcium concentration in the samples, determined by a reference method (which is not explicitly defined here but is implicit in the quantitative nature of the test). There are no human "experts" establishing ground truth in the sense of image interpretation or clinical diagnosis for this type of test.
4. Adjudication Method for the Test Set
This is not applicable for this type of quantitative diagnostic test. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective assessments, such as expert review of medical images, where there might be disagreement among reviewers. For a quantitative chemical assay, the comparison would be against a reference method or known concentrations.
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 and the concept of "human readers improving with AI assistance" are relevant for AI-powered diagnostic tools, especially in radiology or pathology. This document describes a chemical assay kit for calcium determination, which does not involve human interpretation aided by AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not explicitly stated or applicable in the AI-centric sense. The device itself (reagents) is the "algorithm" in this context; its performance is measured directly. The document provides performance characteristics of the device itself (precision). While the test can be used on "manual and automated systems," the performance metrics provided reflect the kit's inherent analytical performance, which is a standalone assessment of the reagents' capability.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for evaluating the performance of a calcium test system would be the actual calcium concentration in the test samples. This is typically determined by:
- Reference materials/calibrators with known calcium concentrations: Used for linearity and calibration verification.
- Split samples analyzed by a well-established, often more precise, reference method (e.g., atomic absorption spectrophotometry or another validated clinical chemistry analyzer): Used for accuracy/bias assessment against patient samples.
The document does not explicitly state which ground truth method was used, but it's implied through the reporting of linearity and precision, which rely on having known or well-characterized samples.
8. The Sample Size for the Training Set
This is not applicable in the traditional sense of machine learning/AI models. The device is a chemical reagent system, not a software algorithm that undergoes a "training phase" on a dataset. The development of such a kit involves chemical formulation and optimization, followed by validation studies.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as #8. There is no training set or ground truth establishment in an AI context. The "development" of the product involves optimizing reagent concentrations and reaction conditions to achieve desired analytical performance, which is then validated.
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SEP 1 0 2002
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WIENER
Section 6 - Summary
510(k) Summary "This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92"
"The assigned 510(k) number is: _____________________________________________________________________________________________________________________________________________ y
| Introduction | According to the requirements of 21 CFR 862.1145, thefollowing information provides sufficient details to understandthe basis of a determination of substantial equivalence. | |
|---|---|---|
| 6-1 SubmitterName, Address,Contact | Wiener Lab GroupRiobamba 29442000 - Rosario - ArgentinaContact person: Viviana CétolaDate Prepared: July, 2002 | |
| 6-2 Device Name | Proprietary name: WIENER LAB. CA-COLOR ARSENAZO IIIAACommon name: Calcium test system.Classification name: Azo Dye, CalciumDevice Class II | |
| 6-3 PredicateDevice | We claim substantial equivalence to the currently marketedWIENER LAB. CA-COLOR AA (Cat. N o 1152002) kit. |
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Calcium reacts with Arsenazo III, vielding a blue colored 6-4 Device complex, which is photocolorimetrically measured at 650 nm. Description 8-hydroxyquinoline is added to remove magnesium interference.
The WIENER LAB. CA-COLOR ARSENAZO III AA test 6-5 Intended Use system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of calcium in human sera, heparinized plasmas and urine on both manual and automated systems. Measurements of calcium are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal diseases and tetany (intermittent muscular contractions or spasms).
The WIENER LAB. CA-COLOR ARSENAZO III AA test 6-6 Equivalencies and Differences system is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed WIENER LAB. CA-COLOR AA test system.
The following table illustrates the similarities and differences between the WIENER LAB. CA-COLOR ARSENAZO III AA test system and the currently marketed WIENER LAB. CA-COLOR AA test system.
| CA-COLOR AA | CA-COLORARSENAZO III AA | |
|---|---|---|
| Intended use | Quantitative determination of calcium in humanserum, heparinized plasma and urine.Continued on next page | |
| CA-COLOR AA | CA-COLORARSENAZO III AA | |
| Test principle | Calcium reacts with o-Cresolphtaleincomplexone (o-CPC) atpH 10.8, yielding apurple colored complex,which isphotocolorimetricallymeasured at 570 nm.8-hydroxyquinoline isadded to removemagnesiuminterference | Calcium reacts withArsenazo III, yielding ablue colored complex,which isphotocolorimetricallymeasured at 650 nm.8-hydroxyquinoline isadded to removemagnesiuminterference |
| EssentialComponents | o-CPC8-hydroxyquinoline | Arsenazo III8-hydroxyquinoline |
| Reagent Storage | Room temperature | 2 - 10°C |
| ReagentDeterioration | Reagent Blank > 0.400O.D. | Reagent turbidityReagent Blank > 0.800O.D. |
| Preparation ofWorking Reagent | Mixture of R1 and R2(1:1) or they can beused separately. | None |
| Working ReagentStability | Stable 4 days at 2-10°C | Same as kit stability |
| Precautions | All glassware should be cleaned with dilutedhydrochloric acid and rinsed with distilled water. | |
| WorkingTemperatures | Room temperature - 37°C | |
| Wavelength ofreading. | 560 - 590 nm | 620 - 650 nm |
| Continued on next page | ||
| CA-COLOR AA | CA-COLORARSENAZO III AA | |
| Linearity | 20 mg/dl | |
| Expected values | Serum: 8.5-10.5 mg/dlUrine: 60-200 mg/24hr | |
| Within-runprecision | Normal Level Serum:CV = 1.28% | Normal Level Serum:CV = 1.93% |
| High Level Serum:CV = 1.30% | High Level Serum:CV = 0.88% | |
| Normal Level UrineCV = 1.06% | Normal Level UrineCV = 2.57% | |
| High Level UrineCV = 0.68% | High Level UrineCV = 1.79% | |
| Run-to-runprecision | Normal Level Serum:CV = 1.74% | Normal Level Serum:CV = 1.74% |
| High Level Serum:CV = 1.70% | High Level Serum:CV = 1.29% | |
| Normal Level UrineCV = 2.50% | Normal Level UrineCV = 2.44% | |
| High Level UrineCV = 1.34% | High Level UrineCV = 2.62% |
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- 6-7 Conclusion Based on the data above mentioned, we believe that the extended claims continue to support substantial equivalence to other products in commercial distribution intended for similar use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 0 2002
Dr. Viviana Cetola QC/QA Manager Weiner Laboratorios S.A.I.C. Riobamba 2944 Rosario, Santa Fe Argentina
Re: K021334
Trade/Device Name: Ca-Color Arsenazo III AA Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY Dated: August 1, 2002 Received: August 13, 2002
Dear Dr. Cetola:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrlvdsmaldsmamain.html".
Sincerely yours,
Steven Putman
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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Page /
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Wiener lats. Arsena 70 III AA Ca -color.
Indications For Use:
The "Wiener lab. Ca-Color Arsenazo III AA" test stem = is quantitative in vitro diagnostic device intended to be "useds in the quantitative determination of calcium in human sera, heparinized plasmas and urine on both manual and automated systems. Measurements of calcium are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal diseases and tetany (intermittent muscular contractions or spasms).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBDBD)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021334
itt
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.