(45 days)
POINTE CALCIUM REAGENT SET (Cat. Nº C7503-120), DMA CALCIUM test system (Cat. Nº 1250)
Not Found
No
The device description and performance studies focus on a chemical reaction and photocolorimetric measurement, with no mention of AI or ML.
No
The device is an in vitro diagnostic (IVD) device used for the quantitative determination of calcium in human samples, which aids in diagnosis and treatment monitoring, rather than providing direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a quantitative in vitro diagnostic device" and that "Measurements of calcium are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal diseases and tetany".
No
The device description clearly outlines a chemical reaction and photocolorimetric measurement, indicating a physical reagent and a measurement system, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"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."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / 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 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 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).
Product codes (comma separated list FDA assigned to the subject device)
CIC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The document provides information on within-run and run-to-run precision for Normal Serum, High Level Serum, Normal Level Urine, and High Level Urine, but does not specify study type or sample size.
Within-run precision:
Normal Level Serum: CV = 1.28%
High Level Serum: CV = 1.30%
Normal Level Urine: CV = 1.06%
High Level Urine: CV = 0.68%
Run-to-run precision:
Normal Level Serum: CV = 1.74%
High Level Serum: CV = 1.70%
Normal Level Urine: CV = 2.50%
High Level Urine: CV = 1.34%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
POINTE CALCIUM REAGENT SET (Cat. Nº C7503-120), DMA CALCIUM test system (Cat. Nº 1250)
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.
Not Found
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).
Not Found
§ 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.
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:
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.
| | POINTE
Test System | WIENER LAB. Test
System |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Quantitative
determination of
calcium in human
serum and heparinized
plasma. | Quantitative
determination of
calcium in human
serum, heparinized
plasma and urine. |
| Continued on next page | | |
| | POINTE
Test System | WIENER LAB. Test
System |
| 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. | |
| Essential
Components | o-CPC
8-hydroxyquinoline | |
| Reagents | R1: o-CPC /
8-hydroxyquinoline
R2: 2-Amino-2-Methyl-
1-Propanol /
Potassium Cyanide | R1: o-CPC /
8-hydroxyquinoline
R2: 2-Amino-2-Methyl-
1-Propanol |
| Reagent Storage | Under refrigeration (2-
8°C) | Room temperature |
| Reagent
Deterioration | Turbid reagent | 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. |
| Working Reagent
Stability | Stable 2 weeks at 2-
10°C and 1 week at
room temperature. | Stable 4 days at 2-10°C |
| Precautions | All glassware should be cleaned with diluted
hydrochloric acid and rinsed with distilled water. | |
| Working
Temperatures | Room temperature | Room temperature -
37°C |
| Wavelength of
reading. | 570 nm | 560 - 590 nm |
| Continued on next page | | |
| | POINTE
Test System | WIENER LAB. Test
System |
| Linearity | 20 mg/dl | |
| Expected values | Serum
8.5 - 10.5 mg/dl
Higher values in
children falling to
normal with aging. | Serum
8.5-10.5 mg/dl
Urine
60-200 mg/24hr |
| Within-run
precision | Normal Serum:
CV = 1.5%
Abnormal Serum:
CV = 1.0% | Normal Level Serum:
CV = 1.28%
High Level Serum:
CV = 1.30%
Normal Level Urine
CV = 1.06%
High Level Urine
CV = 0.68% |
| Run-to-run
precision | Normal Serum:
CV = 1.4%
Abnormal Serum:
CV = 2.1% | Normal Level Serum:
CV = 1.74%
High Level Serum:
CV = 1.70%
Normal Level Urine
CV = 2.50%
High Level Urine
CV = 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.
| | DMA
Test System | WIENER LAB. Test
System |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | 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-
Cresolphtalein
complexone (o-CPC) at
pH 10.8, yielding a
purple colored complex,
which is
photocolorimetrically
measured at 570 nm. | 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. |
| Essential
Components | o-CPC | o-CPC
8-hydroxyquinoline |
| Reagents | R1: o-CPC /
surfactant
R2: Diethylamine /
Potassium Cyanide | R1: o-CPC /
8-hydroxyquinoline
R2: 2-Amino-2-Methyl-
1-Propanol |
| Reagent Storage | Room temperature | |
| Continued on next page | | |
| | DMA
Test System | WIENER LAB. Test
System |
| Reagent
Deterioration | 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) or they can be used
separately. | |
| Working Reagent
Stability | Stable 3 days at room
temperature. | Stable 4 days at 2-10°C |
| Precautions | All glassware should be cleaned with diluted
hydrochloric acid and rinsed with distilled water. | |
| Working
Temperatures | 30°C - 37°C | Room temperature -
37°C |
| Wavelength of
reading. | 550 - 585 nm | 560 - 590 nm |
| Linearity | 15 mg/dl | 20 mg/dl |
| Expected values | 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 | Normal Serum:
CV = 1.98%
Abnormal Serum:
CV = 1.40% | Normal Level Serum:
CV = 1.28%
High Level Serum:
CV = 1.30%
Normal Level Urine
CV = 1.06%
High Level Urine
CV = 0.68% |
| | DMA
Test System | WIENER LAB. Test
System |
| Run-to-run
precision | Normal Serum:
CV = 1.93% | Normal Level Serum:
CV = 1.74% |
| | Abnormal Serum:
CV = 2.40% | High Level Serum:
CV = 1.70% |
| | | Normal Level Urine
CV = 2.50%
High Level Urine
CV = 1.34% |
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:
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)
$\frac{CH}{H}$
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