(45 days)
The "Wiener lab. Ca-Color 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 o-Cresolphtalein complexone (o-CPC) at pH 10.8, yielding a purple colored complex, which is photocolorimetrically measured at 570 nm. magnesium 8-hydroxyquinoline is added to remove interference.
This document describes the WIENER LAB. CA-COLOR AA test system, a quantitative in vitro diagnostic device for the determination of calcium in human sera, heparinized plasmas, and urine. The submission is a 510(k) premarket notification claiming substantial equivalence to predicate devices. The study presented focuses on demonstrating equivalence through performance characteristics of the new device and comparing them to those of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct thresholds in the provided text. Instead, the study aims to show that the performance of the WIENER LAB. CA-COLOR AA test system is "substantially equivalent" to the predicate devices. Therefore, the "acceptance criteria" are implicitly defined by the reported performance of the predicate devices and the similarity of the WIENER LAB. CA-COLOR AA system's performance to these benchmarks.
A direct comparison is provided against two predicate devices: POINTE CALCIUM REAGENT SET (for serum/plasma) and DMA CALCIUM test system (for urine).
| Performance Characteristic | Predicate: POINTE Test System (Serum/Plasma) | Predicate: DMA Test System (Urine) | WIENER LAB. CA-COLOR AA Test System (Reported Performance) |
|---|---|---|---|
| Intended Use | Quantitative determination of calcium in human serum and heparinized plasma. | Quantitative determination of calcium in human serum and urine. | Quantitative determination of calcium in human serum, heparinized plasma, and urine. |
| Test Principle | Calcium reacts with o-Cresolphthalein 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 o-Cresolphthalein complexone (o-CPC) at pH 10.8, yielding a purple colored complex, which is photocolorimetrically measured at 570 nm. | Calcium reacts with o-Cresolphthalein 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. |
| Essential Components | o-CPC, 8-hydroxyquinoline | o-CPC | o-CPC, 8-hydroxyquinoline |
| Reagents | R1: o-CPC / 8-hydroxyquinoline, R2: 2-Amino-2-Methyl-1-Propanol / Potassium Cyanide | R1: o-CPC / surfactant, R2: Diethylamine / Potassium Cyanide | R1: o-CPC / 8-hydroxyquinoline, R2: 2-Amino-2-Methyl-1-Propanol |
| Reagent Storage | Under refrigeration (2-8°C) | Room temperature | Room temperature |
| Reagent Deterioration | Turbid reagent | R1 darkened or with precipitate, R2 turbid or colored, Reagent Blank > 0.500 O.D. | Reagent Blank > 0.400 O.D. |
| Preparation of Working Reagent | Mixture of R1 and R2 (1:1) | Mixture of R1 and R2 (1:1) or they can be used separately. | Mixture of R1 and R2 (1:1) or they can be used separately. |
| Working Reagent Stability | Stable 2 weeks at 2-10°C and 1 week at room temperature. | Stable 3 days at room temperature. | Stable 4 days at 2-10°C |
| Working Temperatures | Room temperature | 30°C - 37°C | Room temperature - 37°C |
| Wavelength of Reading | 570 nm | 550 - 585 nm | 560 - 590 nm |
| Linearity | 20 mg/dl | 15 mg/dl | 20 mg/dl |
| Expected Values | Serum: 8.5 - 10.5 mg/dl; Higher values in children falling to normal with aging. (No urine data provided for POINTE) | Serum: 8.5 - 11.0 mg/dl, Urine: 100-300 mg/24hr | Serum: 8.5-10.5 mg/dl, Urine: 60-200 mg/24hr |
| Within-run precision (Serum) | Normal Serum: CV = 1.5%; Abnormal Serum: CV = 1.0% | Normal Serum: CV = 1.98%; Abnormal Serum: CV = 1.40% | Normal Level Serum: CV = 1.28%; High Level Serum: CV = 1.30% |
| Within-run precision (Urine) | N/A | N/A | Normal Level Urine CV = 1.06%; High Level Urine CV = 0.68% |
| Run-to-run precision (Serum) | Normal Serum: CV = 1.4%; Abnormal Serum: CV = 2.1% | Normal Serum: CV = 1.93%; Abnormal Serum: CV = 2.40% | Normal Level Serum: CV = 1.74%; High Level Serum: CV = 1.70% |
| Run-to-run precision (Urine) | N/A | N/A | Normal Level Urine CV = 2.50%; High Level Urine CV = 1.34% |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for the precision, linearity, or expected values studies. It only reports the calculated Coefficient of Variation (CV) for precision studies or the linearity range. The provenance of the data (e.g., country of origin, retrospective or prospective nature) is also not specified.
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)
This document describes an in vitro diagnostic (IVD) device, specifically a calcium test system. The "ground truth" for such devices is typically established through reference methods or established clinical laboratory best practices for measuring analyte concentrations (e.g., calcium). Experts involved would likely be clinical chemists or laboratory professionals, but the document does not specify the number or qualifications of any experts involved in establishing ground truth for the test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The provided text does not mention any adjudication method, as it pertains to the performance characteristics of an IVD reagent system rather than image-based diagnostic expert review.
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
No such study was performed or described. This is an IVD reagent system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This document describes the performance of a chemical reagent system. The "standalone performance" refers to the device's ability to measure calcium concentrations accurately and precisely as per its design. The reported precision and linearity data represent the standalone performance of the WIENER LAB. CA-COLOR AA test system. There is no "algorithm" in the sense of machine learning described here; the measurement is photocolorimetric.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance characteristics reported (linearity, precision, expected values) would be derived from:
- Known concentrations of calcium in control samples for linearity and precision studies. These would be established using validated reference methods or certified reference materials.
- Clinically established ranges for calcium in serum and urine for the "expected values." These ranges are typically derived from large population studies using validated methods.
The document does not explicitly detail the methodologies used to establish these ground truths, but these are standard practices for IVD device validation.
8. The sample size for the training set
This document describes a chemical reagent system, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The development of the reagent system involves chemical formulation and optimization studies, but these do not typically involve "training sets" in the same way an AI algorithm does.
9. How the ground truth for the training set was established
As there is no "training set" in the context of AI/ML for this device, this question is not applicable. The development of the reagent system relies on established chemical principles for colorimetric assays and analytical validation against known calcium standards.
{0}------------------------------------------------
DEC 21 2001
Image /page/0/Picture/2 description: The image is a black and white circular logo or seal. The text "Wiener lab." is at the top of the circle, and "SISTEMA DE CALIDAD CERTIFICADO" is at the bottom. Inside the circle are the words "ISO 9001" and the logo for "TUV CERT".
Image /page/0/Picture/3 description: The image shows the logo for Wiener lab. The logo consists of a stylized "W" inside of a circle on the left, followed by the text "Wiener lab." in bold font. Below the company name is the text "Especialidades para Laboratorios Clinicos" in a smaller font.
WIENER LABORATORIOS S.A.I.C. - Riobamba 2944 - 2000 Rosario - Argentina
Phone +54 (341) 432-9191/6 - Fax +54 (341) 432-5454/5555
Internet: http://www.wiener-lab.com.ar
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"
KO13652 " "The assigned 510(k) number is: __
According to the requirements of 21 CFR 862.1145, the Introduction following information provides sufficient details to understand the basis of a determination of substantial equivalence.
Wiener Lab Group 6-1 Submitter Riobamba 2944 Name, Address, 2000 - Rosario - Argentina Contact Contact person: Viviana Cétola Date Prepared: August 28, 2001
Proprietary name: WIENER LAB. CA-COLOR AA 6-2 Device Name Common name: Calcium test system. Classification name: Cresolphthalein Complexone, Calcium Device Class II
We claim substantial equivalence to the currently marketed 6-3 Predicate POINTE CALCIUM REAGENT SET (Cat. Nº C7503-120) for Device the serum / plasma application and DMA CALCIUM test system (Cat. Nº 1250) for the urine application..
{1}------------------------------------------------
Calcium reacts with o-Cresolphtalein complexone (o-CPC) at 6-4 Device pH 10.8, yielding a purple colored complex, which is Description photocolorimetrically measured at 570 nm. magnesium 8-hydroxyquinoline is added to remove interference.
The WIENER LAB. CA-COLOR AA test system is a 6-5 Intended Use 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 AA test system is substantially 6-6 Equivalencies equivalent to other products in commercial distribution and Differences intended for similar use. Most notably it is substantially equivalent to the currently marketed POINTE CALCIUM REAGENT SET for the serum / plasma application and DMA CALCIUM test system for the urine application.
The following table illustrates the similarities and differences between the WIENER LAB. CA-COLOR AA test system and the currently marketed POINTE CALCIUM REAGENT SET.
| POINTETest System | WIENER LAB. TestSystem | |
|---|---|---|
| Intended use | Quantitativedetermination ofcalcium in humanserum and heparinizedplasma. | Quantitativedetermination ofcalcium in humanserum, heparinizedplasma and urine. |
| Continued on next page | ||
| POINTETest System | WIENER LAB. TestSystem | |
| Test principle | Calcium reacts with o-Cresolphtalein complexone(o-CPC) at pH 10.8, yielding a purple coloredcomplex, which is photocolorimetricallymeasured at 570 nm.8-hydroxyquinoline is added to removemagnesium interference. | |
| EssentialComponents | o-CPC8-hydroxyquinoline | |
| Reagents | R1: o-CPC /8-hydroxyquinolineR2: 2-Amino-2-Methyl-1-Propanol /Potassium Cyanide | R1: o-CPC /8-hydroxyquinolineR2: 2-Amino-2-Methyl-1-Propanol |
| Reagent Storage | Under refrigeration (2-8°C) | Room temperature |
| ReagentDeterioration | Turbid reagent | Reagent Blank > 0.400O.D. |
| Preparation ofWorking Reagent | Mixture of R1 and R2(1:1) | Mixture of R1 and R2(1:1) or they can beused separately. |
| Working ReagentStability | Stable 2 weeks at 2-10°C and 1 week atroom temperature. | Stable 4 days at 2-10°C |
| Precautions | All glassware should be cleaned with dilutedhydrochloric acid and rinsed with distilled water. | |
| WorkingTemperatures | Room temperature | Room temperature -37°C |
| Wavelength ofreading. | 570 nm | 560 - 590 nm |
| Continued on next page | ||
| POINTETest System | WIENER LAB. TestSystem | |
| Linearity | 20 mg/dl | |
| Expected values | Serum8.5 - 10.5 mg/dlHigher values inchildren falling tonormal with aging. | Serum8.5-10.5 mg/dlUrine60-200 mg/24hr |
| Within-runprecision | Normal Serum:CV = 1.5%Abnormal Serum:CV = 1.0% | Normal Level Serum:CV = 1.28%High Level Serum:CV = 1.30%Normal Level UrineCV = 1.06%High Level UrineCV = 0.68% |
| Run-to-runprecision | Normal Serum:CV = 1.4%Abnormal Serum:CV = 2.1% | Normal Level Serum:CV = 1.74%High Level Serum:CV = 1.70%Normal Level UrineCV = 2.50%High Level UrineCV = 1.34% |
| Continued on next page |
{2}------------------------------------------------
{3}------------------------------------------------
:
:
Sale
. . . .
{4}------------------------------------------------
The following table illustrates the similarities and differences The following table fillustral critical CineTiCA AA test between the virently marketed DMA CALCIUM test system.
| DMATest System | WIENER LAB. TestSystem | |
|---|---|---|
| Intended use | Quantitativedetermination ofcalcium in humanserum and urine. | Quantitativedetermination ofcalcium in humanserum, heparinizedplasma and urine. |
| Test principle | Calcium reacts with o-Cresolphtaleincomplexone (o-CPC) atpH 10.8, yielding apurple colored complex,which isphotocolorimetricallymeasured at 570 nm. | Calcium reacts with o-Cresolphtaleincomplexone (o-CPC) atpH 10.8, yielding apurple colored complex,which isphotocolorimetricallymeasured at 570 nm.8-hydroxyquinoline isadded to removemagnesiuminterference. |
| EssentialComponents | o-CPC | o-CPC8-hydroxyquinoline |
| Reagents | R1: o-CPC /surfactantR2: Diethylamine /Potassium Cyanide | R1: o-CPC /8-hydroxyquinolineR2: 2-Amino-2-Methyl-1-Propanol |
| Reagent Storage | Room temperature | |
| Continued on next page | ||
| DMATest System | WIENER LAB. TestSystem | |
| ReagentDeterioration | R1 darkened or withprecipitateR2 turbid or coloredReagent Blank > 0.500O.D. | Reagent Blank > 0.400O.D. |
| Preparation ofWorking Reagent | Mixture of R1 and R2 (1:1) or they can be usedseparately. | |
| Working ReagentStability | Stable 3 days at roomtemperature. | Stable 4 days at 2-10°C |
| Precautions | All glassware should be cleaned with dilutedhydrochloric acid and rinsed with distilled water. | |
| WorkingTemperatures | 30°C - 37°C | Room temperature -37°C |
| Wavelength ofreading. | 550 - 585 nm | 560 - 590 nm |
| Linearity | 15 mg/dl | 20 mg/dl |
| Expected values | Serum8.5 - 11.0 mg/dlUrine100-300 mg/24hr | Serum8.5-10.5 mg/dlUrine60-200 mg/24hr |
| Within-runprecision | Normal Serum:CV = 1.98%Abnormal Serum:CV = 1.40% | Normal Level Serum:CV = 1.28%High Level Serum:CV = 1.30%Normal Level UrineCV = 1.06%High Level UrineCV = 0.68% |
| DMATest System | WIENER LAB. TestSystem | |
| Run-to-runprecision | Normal Serum:CV = 1.93% | Normal Level Serum:CV = 1.74% |
| Abnormal Serum:CV = 2.40% | High Level Serum:CV = 1.70% | |
| Normal Level UrineCV = 2.50%High Level UrineCV = 1.34% |
{5}------------------------------------------------
· --------
11 - 11 - 11
:
ﺍﻟﻤﻮﺍﺻﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ
{6}------------------------------------------------
Based on the data above mentioned, we believe that the 6-7 Conclusion extended claims continue to support substantial equivalence to other products in commercial distribution intended for similar use.
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird with outstretched wings, positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the circumference of the circle. The logo is presented in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 1 2001
Dr. Viviana Cetola OC/OA Manager Weiner Laboratorios S.A.I.C. 2944 Riobamba Rosario, Santa Fe Argentina
Re: K013652
Trade/Device Name: Weiner Lab. CA-COLOR AA Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CIC Dated: October 15, 2001 Received: November 6, 2001
Dear Dr. Cetola:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave a rowed your 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 I ou may a 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 may or subject to been 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 or any I cather bather 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 Of It Fart 6777 accems (21 (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.
{8}------------------------------------------------
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 1 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, (Jease 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
{9}------------------------------------------------
CDkil Over
Page _ of _
| 510(k) Number (if known): | K013652 |
|---|---|
| Device Name: | Wiener lab. |
| CA-COLOR AA |
10013652
Indications For Use:
The "Wiener lab. Ca-Color AA" test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination diagnootio actionwan sera, heparinized plasmas and urine on both or ourolum in hamated systems. Measurements of calcium are used in the diagnosis and treatment of parathyroid diseases, a variety of bone the diagnoois and trenal diseases and tetany (intermittent muscular contractions or spasms)
| contractions of spasms). | |
|---|---|
| K013652 - Manuel C.Hurt for Jean Cooper | |
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K013652 |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBDED)
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)
$\frac{CH}{H}$
Sh
§ 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.