(68 days)
DMA CK NAC test system (Cat. Nº 1380-200), RANDOX CK NAC-activated kit (Cat. Nº CK522)
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No
The summary describes a chemical assay for measuring enzyme activity, which is a standard laboratory technique and does not mention any AI or ML components.
No
This device is for diagnostic purposes, specifically measuring enzyme activity to aid in the diagnosis and treatment of certain diseases, rather than providing therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements of creatine phosphokinase and isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases". This indicates the device provides information used for diagnostic purposes.
No
The device is a test system intended to measure enzyme activity, which implies the use of reagents and potentially hardware components like analyzers, not solely software.
Yes, based on the provided information, the "Wiener lab. CK-NAC UV" test system is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to measure the activity of the enzyme creatine phosphokinase in plasma and serum". This involves testing biological samples (plasma and serum) in vitro (outside the body).
- Diagnostic Purpose: The intended use also states that these measurements "are used in the diagnosis and treatment of myocardial infarction and muscle diseases". This clearly indicates a diagnostic purpose.
- Methodology: The description mentions "manual methodology and automated clinical chemistry analyzers," which are typical methods used for in vitro diagnostic testing.
Therefore, the device fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The "Wiener lab. CK-NAC UV" test system is a device" Theended to measure the activity of the enzyme creatine phosphokinase in Masma and serum with manual methodology and automated clining chemistry analyzers. Measurements of creatine phosphokinase and isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Product codes (comma separated list FDA assigned to the subject device)
CGS
Device Description
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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
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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)
Comparison of essential components, reagent deterioration, working reagent stability, sample type, working temperatures, wavelength of reading, linearity, instructions for samples exceeding linearity, expected values, within-run precision, and run-to-run precision between the subject device and predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Within-run precision (Normal Serum): CV = 2.33%
- Within-run precision (Abnormal Serum): CV = 1.33%
- Run-to-run precision (Normal Serum): CV = 2.12%
- Run-to-run precision (Abnormal Serum): CV = 1.53%
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.
DMA CK NAC test system (Cat. Nº 1380-200), RANDOX CK NAC-activated kit (Cat. Nº CK522)
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
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.
0
3 2002
CK-NAC UV Wiener lab.
Image /page/0/Picture/2 description: The image is a circular seal or logo. The text "WIENER lab." is arranged around the top of the circle, and "SISTEMA DE CALIDAD CERTIFICADO" is arranged around the bottom. In the center of the circle, there is a stylized "W" logo, followed by the text "ISO 9001" and a "TUV CERT" logo.
Image /page/0/Picture/3 description: The image shows the logo for Wiener lab. The logo consists of a circular emblem with the letter W inside, followed by the text "Wiener lab." in a bold, sans-serif font. Below the company name, there is the text "Especialidades para Laboratorios Clínicos" 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"
"The assigned 510(k) number is: _2 3 3 3 3 3 3 3 3 3 3 2 3 3 2 3 2 3 2
-
According to the requirements of 21 CFR 862.1215, the follow-Introduction ing information provides sufficient details to understand the basis of a determination of substantial equivalence.
Wiener Lab Group 6-1 Submitter Name, Address. Riobamba 2944 2000 - Rosario - Argentina Contact Contact person: Viviana Cétola Date Prepared: March 28, 2002. -
Proprietary name: WIENER LAB. CK-NAC UV 6-2 Device Name Common name: Creatine Phosphokinase/Creatine Kinase test svstem. Classification name: NAD Reduction/NADH Oxidation, CPK or lsoenzymes. Device Class II
-
6-3 Predicate De-We claim substantial equivalence to the currently marketed DMA CK NAC test system (Cat. Nº 1380-200) and RANDOX vice CK NAC-activated kit (Cat. Nº CK522).
1
Image /page/1/Figure/1 description: This image describes the device and intended use of the WIENER LAB. CK-NAC UV test system. The reaction system involves creatine phosphate, ADP, ATP, glucose, glucose-6-P, and NADP+. The test system measures creatine phosphokinase activity in plasma and serum and is substantially equivalent to other products like DMA CK NAC and RANDOX CK NAC.
currently marketed DMA CK NAC test system.
2
| | OMA
Test System | WIENER LAB. Test
System | |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--|
| Intended use | Quantitative determina-
tion of Creatine Kinase
in human serum. | Quantitative determina-
tion of Creatine Kinase
in human serum and
heparinized plasma. | |
| | The reaction system is as follows: | | |
| Test principle | Creatine phosphate + ADP | ск
Creatine + ATP | |
| | HK
ATP + Glucose
Glucose-6-P + NADP+ | ADP + Glucose-6-P
G-6-PDH | |
| | Gluconate-6-P + NADPH + H*
In the reaction system. NAC works as activator of
the Creatine Kinase, recommended by the IFCC. | | |
| | CK: Creatine Kinase
HK: Hexokinase
G-6-PDH: Glucose-6-phosphate dehydrogenase | | |
| Essential Compo-
nents | Creatine phosphate -
ADP - Glucose - HK -
NAD - G-6PDH - NAC | Creatine phosphate -
ADP - Glucose - HK -
NADP - G-6PDH - NAC | |
| Reagent Deterio-
ration | Reagent must be a
white powder
Reagent blank > 0.600
O.D. at 340 nm | Reagent blank > 0.800
O.D. at 340 nm | |
| Working Reagent
Stability | Stable 21 days at 2-
10°C | Stable 20 days at 2-
10°C or 3 days at room
temperature. | |
| Sample | Human serum | Human serum and hepa-
rinized plasma | |
| Continued on next page | | | |
| | DMA
Test System | WIENER LAB. Test
System | |
| Working Tem-
peratures | 30°C or 37°C | 25°C, 30°C or 37°C | |
| Wavelength of
reading. | 340 nm | 334 nm - 340 nm - 366
nm | |
| Linearity | 1,500 U/l (30°C) -
2,300 U/l (37°C) | 2,000 U/l (37°C) | |
| Instructions for
samples exceed-
ing linearity | Dilution in saline and correction of result | | |
| Expected values | 7-114 U/l (30°C)
25-160 U/l (37°C) | Male:
≤80 U/l (25°C)
≤130 U/l (30°C)
≤195 U/l (37°C)
Female:
≤70 U/l (25°C)
≤110 U/l (30°C)
≤170 U/l (37°C) | |
| Within-run preci-
sion | Normal Serum:
CV = 2.7%
Abnormal Serum:
CV = 3.9% | Normal Serum:
CV = 2.33%
Abnormal Serum:
CV = 1.33% | |
| Run-to-run preci-
sion | Normal Serum:
CV = 2.9%
Abnormal Serum:
CV = 4.2% | Normal Serum:
CV = 2.12%
Abnormal Serum:
CV = 1.53% | |
| | | Continued on next page | |
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4
The following table illustrates the similarities and differences between the WIENER LAB. CK-NAC UV test system and the currently marketed RANDOX CK NAC-activated system.
| | RANDOX
Test System | WIENER LAB. Test
System |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Quantitative determina-
tion of Creatine Kinase
in human serum, hepa-
rinized or EDTA plasma. | Quantitative determina-
tion of Creatine Kinase
in human serum and
heparinized plasma. |
| Test principle | The reaction system is as follows:
$Creatine phosphate + ADP \xrightarrow{CK} Creatine + ATP$ $ATP + Glucose \xrightarrow{HK} ADP + Glucose-6-P$ $Glucose-6-P + NADP^+ \xrightarrow{G-6-PDH} Gluconate-6-P + NADPH + H^+$ CK: Creatine Kinase
HK: Hexokinase
G-6-PDH: Glucose-6-phosphate dehydrogenase | |
| Essential Compo-
nents | Creatine phosphate – ADP – Glucose – HK –
NADP – G-6PDH – NAC | |
| Working Reagent
Stability | Stable 3 weeks at 2-8°C
or 3 days at 15-25°C | Stable 20 days at 2-
10°C or 3 days at room
temperature. |
| Sample | Human serum, heparin-
ized or EDTA plasma | Human serum and hepa-
rinized plasma |
| | RANDOX
Test System | WIENER LAB. Test
System |
| Working Reagent
Stability | Stable 3 weeks at 2-8ºC
or 3 days at 15-25ºC | Stable 20 days at 2-
10℃ or 3 days at room
temperature. |
| Sample | Human serum, heparin-
ized or EDTA plasma | Human serum and hepa-
rinized plasma |
| Working Tem-
peratures | 25°C, 30°C or 37°C | |
| Wavelength of
reading. | 334 nm - 340 nm - 365
nm | 334 nm - 340 nm - 366
nm |
| Linearity | O.D. 0.25 at 340 nm /
334 nm
O.D. 0.14 at 365 nm | 2,000 Ull (37°C) |
| Instructions for
samples exceed-
ing linearity | Dilution in saline and correction of result | |
| Expected values | Male:
10-80 U/I (25°C)
15-130 UN (30°C)
24-195 UI (37°C)
Female:
10-70 UJI (25°C)
15-110 U/I (30ºC)
24-170 U/l (37°C) | Male:
Trade/Device Name: CK-NAC UV Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: CGS Dated: April 17, 2002 Received: April 26, 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 vour 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/cdch/dsma/dsmamain.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
9
CDRH ODE
Page
DUPLICATE
510(k) Number (if known):
Device Name: Wiener lab.
. UV
Indications For Use:
The "Wiener lab. CK-NAC UV" test system is a device" Theended to measure the activity of the enzyme creatine phosphokinase in Masma and serum with manual methodology and automated clining chemistry analyzers. Measurements of creatine phosphokinase and isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Cooper
(Division 3.2-01)
Division of Clinical Laboratory
510(k) Number K021332
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDBO)
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)