K Number
K021334
Device Name
WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5
Date Cleared
2002-09-10

(137 days)

Product Code
Regulation Number
862.1145
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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).
Device Description
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.
More Information

1152002

Not Found

No
The device description and performance studies focus on a chemical reaction and photocolorimetric measurement, with no mention of AI or ML terms or concepts.

No
The device is an in vitro diagnostic (IVD) test system used to measure calcium levels, which aids in diagnosis and treatment monitoring, but it does not directly treat a disease or condition.

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 indicates a chemical reaction and photocolorimetric measurement, which are hardware-based processes, 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 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."

This statement directly identifies the device as an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

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).

Product codes

CJY

Device Description

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.

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

The document lists "Within-run precision" and "Run-to-run precision" for Normal Level Serum, High Level Serum, Normal Level Urine, and High Level Urine, with corresponding CV values for both the subject device and the predicate device.

Key Metrics

Within-run precision:
Normal Level Serum: CV = 1.93%
High Level Serum: CV = 0.88%
Normal Level Urine: CV = 2.57%
High Level Urine: CV = 1.79%

Run-to-run precision:
Normal Level Serum: CV = 1.74%
High Level Serum: CV = 1.29%
Normal Level Urine: CV = 2.44%
High Level Urine: CV = 2.62%

Predicate Device(s)

WIENER LAB. CA-COLOR AA (Cat. No 1152002) kit.

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

SEP 1 0 2002

Image /page/0/Picture/3 description: The image shows the logo for Wiener lab. The logo consists of a circular graphic on the left and the text "Wiener lab." on the right. Below the text is the phrase "Especialidades para Laboratorios Clinicos".

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, the
following information provides sufficient details to understand
the basis of a determination of substantial equivalence. | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 6-1 Submitter
Name, Address,
Contact | Wiener Lab Group
Riobamba 2944
2000 - Rosario - Argentina
Contact person: Viviana Cétola
Date Prepared: July, 2002 | |
| 6-2 Device Name | Proprietary name: WIENER LAB. CA-COLOR ARSENAZO III
AA
Common name: Calcium test system.
Classification name: Azo Dye, Calcium
Device Class II | |
| 6-3 Predicate
Device | We claim substantial equivalence to the currently marketed
WIENER LAB. CA-COLOR AA (Cat. N o 1152002) kit. | |

1

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-COLOR
ARSENAZO III AA |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Quantitative determination of calcium in human
serum, heparinized plasma and urine.
Continued on next page | |
| | CA-COLOR AA | CA-COLOR
ARSENAZO III AA |
| 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 |
| Essential
Components | o-CPC
8-hydroxyquinoline | Arsenazo III
8-hydroxyquinoline |
| Reagent Storage | Room temperature | 2 - 10°C |
| Reagent
Deterioration | Reagent Blank > 0.400
O.D. | Reagent turbidity
Reagent Blank > 0.800
O.D. |
| Preparation of
Working Reagent | Mixture of R1 and R2
(1:1) or they can be
used separately. | None |
| Working Reagent
Stability | Stable 4 days at 2-10°C | Same as kit stability |
| Precautions | All glassware should be cleaned with diluted
hydrochloric acid and rinsed with distilled water. | |
| Working
Temperatures | Room temperature - 37°C | |
| Wavelength of
reading. | 560 - 590 nm | 620 - 650 nm |
| | | Continued on next page |
| | CA-COLOR AA | CA-COLOR
ARSENAZO III AA |
| Linearity | 20 mg/dl | |
| Expected values | Serum: 8.5-10.5 mg/dl
Urine: 60-200 mg/24hr | |
| Within-run
precision | 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 Urine
CV = 1.06% | Normal Level Urine
CV = 2.57% |
| | High Level Urine
CV = 0.68% | High Level Urine
CV = 1.79% |
| Run-to-run
precision | 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 Urine
CV = 2.50% | Normal Level Urine
CV = 2.44% |
| | High Level Urine
CV = 1.34% | High Level Urine
CV = 2.62% |

2

3

  • 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.

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the perimeter. Inside the circle is an emblem that resembles a stylized caduceus, with three horizontal lines above a wavy line. The emblem is black, and the background is white.

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.

5

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

6

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