(224 days)
Not Found
No
The description focuses on a chemical reagent and a photometric test, with no mention of AI or ML.
No
This device is an in vitro diagnostic reagent used to determine carbon dioxide concentration in serum or plasma, not to treat or cure a disease.
Yes
The Intended Use/Indications for Use section states that measurements are "used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance."
No
The device description clearly states it is a reagent cartridge containing chemical components, which is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only."
- Purpose: The device is intended for the "quantitative determination of carbon dioxide concentration in serum or heparin plasma." This is a test performed on biological samples outside of the body to provide information for diagnosis and treatment.
- Device Description: The description further clarifies that it's for "quantitative in vitro diagnostic determination of CO2 in serum or heparin plasma."
- Care Setting: It is intended for use in "clinical laboratories or physician office laboratories," which are typical settings for performing in vitro diagnostic tests.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The S-Test Carbon Dioxide Reagent is intended for the quantitative determination of carbon dioxide concentration in serum or heparin plasma using the S40 Clinical Analyzer. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
KHS
Device Description
The S-Test Carbon dioxide (CO2) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of CO2 in serum or heparin plasma based on a photometric test measuring the formation of an enzymatic cofactor in a coupled enzymatic reaction.
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
clinical laboratories or physician office laboratories.
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)
Performance data on the S-Test CO2 included precision, accuracy, and sensitivity data.
Precision: In testing conducted at three CO2 levels for 21 days, the within-run CV ranged from 1.7 to 3.0%, and total CV ranged from 5.7 to 6.7%. In precision studies at three separate Physician Office Laboratory (POL) sites and in-house over five or more days, the within-run CV ranged from 1.3 to 6.6% and total CV ranged from 2.0 to 6.6%.
Accuracy: In the correlation study, 94 samples with CO2 values ranging from 6.0 to 41.8 mEq/L were assayed on the S40 Clinical Analyzer using S-Test CO2 and a comparison method. Least-squares regression analysis yielded a correlation coefficient of 0.984, a standard error estimate of 1.1, a confidence interval slope of 0.940 to 1.029, and a confidence interval intercept of -0.6 to 1.5. In patient correlation studies at three separate POL sites using the S40 Clinical Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients ranging from 0.937 to 0.980, standard error estimates ranging from 1.40 to 2.65, confidence interval slopes ranging from 0.880 to 1.080, and confidence interval intercepts ranging from -1.73 to 2.03.
Sensitivity: The detection limit was 5 mEq/L.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: The detection limit was 5 mEq/L.
Precision: In testing conducted at three CO2 levels for 21 days, the within-run CV ranged from 1.7 to 3.0%, and total CV ranged from 5.7 to 6.7%. In precision studies at three separate Physician Office Laboratory (POL) sites and in-house over five or more days, the within-run CV ranged from 1.3 to 6.6% and total CV ranged from 2.0 to 6.6%.
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.
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
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.
0
JUN 2 6 2008
510(k) SUMMARY
| 510(k) Owner: | Alfa Wassermann Diagnostic Technology, LLC
4 Henderson Drive
West Caldwell, NJ 07006 | | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--|
| Contact: | Dennis Taschek
Phone: 973-852-0177
Fax: 973-852-0237 | | |
| Date Summary
Prepared: | June 19, 2008 | | |
| Device: | Trade Name: | S-Test CO2 Reagent cartridge | |
| | Common/Classification Name: | Carbon dioxide test system
(21 C.F.R. § 862.1160)
Product Code KHS | |
| | Classification: | Class II | |
| Predicate
Devices: | Manufacturers for analyzer/reagent system predicates are:
- ACE plus ISE/Clinical Chemistry System
ACE Carbon Dioxide Reagent (K931786) - Ortho Clinical Diagnostics Fusion Clinical Chemistry Analyzer
Carbon Dioxide Reagent (K946090) - Piccolo® xpress Chemistry Analyzer
Carbon Dioxide Reagent (K942782) | | |
| Device
Description: | The S-Test Carbon dioxide (CO2) reagent cartridge, used with the S40
Clinical Analyzer, is intended for quantitative in vitro diagnostic
determination of CO2 in serum or heparin plasma based on a
photometric test measuring the formation of an enzymatic cofactor in a
coupled enzymatic reaction. | | |
| Intended Use: | The S-Test Carbon Dioxide Reagent is intended for the quantitative
determination of carbon dioxide concentration in serum or heparin
plasma using the S40 Clinical Analyzer. Bicarbonate/carbon dioxide
measurements are used in the diagnosis and treatment of numerous
potentially serious disorders associated with changes in body acid-base
balance. This test is intended for use in clinical laboratories or
physician office laboratories. For in vitro diagnostic use only. | | |
:
1
| Technological
Characteristics: | The S-Test CO2 Reagent is contained in a bi-reagent cartridge.
Reagent 1 contains water and a preservative. Reagent 2 contains
phosphoenolpyruvate, nicotinamide adenine dinucleotide analog
(reduced), phosphoenol pyruvate carboxylase, and malate
dehydrogenase. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Data: | Performance data on the S-Test CO2 included precision, accuracy, and
sensitivity data.
Precision: In testing conducted at three CO2 levels for 21 days, the
within-run CV ranged from 1.7 to 3.0%, and total CV ranged from 5.7
to 6.7%. In precision studies at three separate Physician Office
Laboratory (POL) sites and in-house over five or more days, the
within-run CV ranged from 1.3 to 6.6% and total CV ranged from 2.0
to 6.6%.
Accuracy: In the correlation study, 94 samples with CO2 values
ranging from 6.0 to 41.8 mEq/L were assayed on the S40 Clinical
Analyzer using S-Test CO2 and a comparison method. Least-squares
regression analysis yielded a correlation coefficient of 0.984, a standard
error estimate of 1.1, a confidence interval slope of 0.940 to 1.029, and
a confidence interval intercept of -0.6 to 1.5. In patient correlation
studies at three separate POL sites using the S40 Clinical Analyzer and
a comparative method, least-squares regression analysis yielded
correlation coefficients ranging from 0.937 to 0.980, standard error
estimates ranging from 1.40 to 2.65, confidence interval slopes ranging
from 0.880 to 1.080, and confidence interval intercepts ranging from
-1.73 to 2.03.
Sensitivity: The detection limit was 5 mEq/L. |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These
data also indicate substantial equivalence to the predicate devices. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 6 2008
Alfa Wassermann Diagnostic Technologies, Inc. c/o Mr. Daivd Slavin Vice President, Quality and Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006
Re: K073223/S1
Trade/Device Name: S Test Carbon Dioxide (CO2) Reagent Cartridge Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II, Product Code: KHS Dated: November 15, 2007 Received: November 15, 2007
Dear Mr. Slavin
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of in Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K073223
S40 Clinical Analyzer S-Test CO2
Indications for Use Statement
510(k) Number K073223 (if known):
S-Test Carbon Dioxide (CO2) Device Name:
The S-Test Carbon Dioxide Reagent is intended for the quantitative Indications for Use: determination of carbon dioxide concentration in serum or heparin plasma using the S40 Clinical Analyzer. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
| Prescription Use | X | And/Or | Over the Counter Use ______ |
|---|---|---|---|
| (21 CFR Part 801 Subpart D) | (21 CFR Part 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign Off
| June 3, 2008 | Office of In Vitro Diagnostic |
|---|---|
| Device Evaluation and Safety | |
| K73223 |
CONFIDENTIAL