(224 days)
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.
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. 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.
The provided text describes the 510(k) summary for the S-Test CO2 Reagent cartridge, used with the S40 Clinical Analyzer, for the quantitative in vitro diagnostic determination of CO2 in serum or heparin plasma.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or categorical format. Instead, it presents performance data used to demonstrate substantial equivalence. The reported performance is summarized below:
| Performance Metric | Reported Device Performance | Acceptance Criteria (Implicit) |
|---|---|---|
| Precision (Within-run CV) | In-house (21 days, 3 CO2 levels): 1.7% to 3.0% | Not explicitly stated, but results are assumed to be acceptable for clinical use and substantially equivalent to predicates. |
| POL sites (5+ days, 3 CO2 levels): 1.3% to 6.6% | Not explicitly stated, but results are assumed to be acceptable for clinical use and substantially equivalent to predicates. | |
| Precision (Total CV) | In-house (21 days, 3 CO2 levels): 5.7% to 6.7% | Not explicitly stated, but results are assumed to be acceptable for clinical use and substantially equivalent to predicates. |
| POL sites (5+ days, 3 CO2 levels): 2.0% to 6.6% | Not explicitly stated, but results are assumed to be acceptable for clinical use and substantially equivalent to predicates. | |
| Accuracy (Correlation with comparison method) | Correlation Coefficient: 0.984 (across 94 samples, 6.0 to 41.8 mEq/L) | Not explicitly stated, but typically a correlation coefficient close to 1 (e.g., >0.95 or >0.975) is considered excellent for clinical correlation studies. The value of 0.984 is very strong. |
| Standard Error Estimate: 1.1 | Not explicitly stated. | |
| Confidence Interval Slope: 0.940 to 1.029 | Not explicitly stated, but a slope covering 1.0 indicates good agreement. | |
| Confidence Interval Intercept: -0.6 to 1.5 | Not explicitly stated, but an intercept covering 0 indicates good agreement. | |
| Accuracy (Patient correlation at POL sites) | Correlation Coefficients: 0.937 to 0.980 | Not explicitly stated, but generally indicative of good correlation. |
| Standard Error Estimates: 1.40 to 2.65 | Not explicitly stated. | |
| Confidence Interval Slopes: 0.880 to 1.080 | Not explicitly stated, but generally covering 1.0 indicating good agreement. | |
| Confidence Interval Intercepts: -1.73 to 2.03 | Not explicitly stated, but generally covering 0 indicating good agreement. | |
| Sensitivity (Detection Limit) | 5 mEq/L | Not explicitly stated, but typically this is compared to the clinical requirements for detecting low levels of CO2. |
2. Sample size used for the test set and the data provenance
- Sample Size for Accuracy/Correlation Study: 94 samples.
- Sample Size for Precision Studies: Not explicitly stated as a number of individual samples, but conducted at "three CO2 levels" for 21 days for in-house and "three separate Physician Office Laboratory (POL) sites" over "five or more days" for POL precision. This implies multiple measurements per level/site.
- Data Provenance: The studies were conducted "in-house" and at "three separate Physician Office Laboratory (POL) sites." The country of origin is not specified but is implied to be within the United States, given the FDA submission. The nature of the studies (precision, accuracy, sensitivity) suggests they are prospective evaluations of the device's performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for the test set. The ground truth for accuracy was established by a "comparison method" and at "POL sites using the S40 Clinical Analyzer and a comparative method." This implies that the ground truth was derived from a previously validated or predicate method/device, rather than expert consensus on individual samples.
4. Adjudication method for the test set
Not applicable. There is no mention of independent interpretation or adjudication of results by multiple individuals. The performance data is based on quantitative measurements.
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
Not applicable. This device is a diagnostic reagent cartridge used with an analyzer, not an imaging or AI-assisted diagnostic device that involves human readers interpreting diagnostic outputs in the way an MRMC study would assess.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is essentially a standalone (algorithm/device-only) performance study, as the device measures CO2 quantitatively. The stated performance metrics (precision, accuracy, sensitivity) reflect the device's direct analytical capability.
7. The type of ground truth used
The ground truth for the accuracy study was established by a "comparison method" or "comparative method." This typically refers to a well-established, validated, and often predicate or reference method for CO2 measurement. It is not pathology, expert consensus, or outcomes data in this context.
8. The sample size for the training set
Not applicable. This is a chemical reagent and analyzer system, not a machine learning or AI-based device that typically requires a "training set" in the computational sense. The device's operational parameters would have been developed and validated through laboratory testing and optimization, but not referred to as a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a "training set" in the context of this device.
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JUN 2 6 2008
510(k) SUMMARY
| 510(k) Owner: | Alfa Wassermann Diagnostic Technology, LLC4 Henderson DriveWest Caldwell, NJ 07006 | ||
|---|---|---|---|
| Contact: | Dennis TaschekPhone: 973-852-0177Fax: 973-852-0237 | ||
| Date SummaryPrepared: | 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 | ||
| PredicateDevices: | Manufacturers for analyzer/reagent system predicates are:1. ACE plus ISE/Clinical Chemistry SystemACE Carbon Dioxide Reagent (K931786)2. Ortho Clinical Diagnostics Fusion Clinical Chemistry AnalyzerCarbon Dioxide Reagent (K946090)3. Piccolo® xpress Chemistry AnalyzerCarbon Dioxide Reagent (K942782) | ||
| DeviceDescription: | The S-Test Carbon dioxide (CO2) reagent cartridge, used with the S40Clinical Analyzer, is intended for quantitative in vitro diagnosticdetermination of CO2 in serum or heparin plasma based on aphotometric test measuring the formation of an enzymatic cofactor in acoupled enzymatic reaction. | ||
| Intended Use: | The S-Test Carbon Dioxide Reagent is intended for the quantitativedetermination of carbon dioxide concentration in serum or heparinplasma using the S40 Clinical Analyzer. Bicarbonate/carbon dioxidemeasurements are used in the diagnosis and treatment of numerouspotentially serious disorders associated with changes in body acid-basebalance. This test is intended for use in clinical laboratories orphysician office laboratories. For in vitro diagnostic use only. |
:
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| TechnologicalCharacteristics: | The S-Test CO2 Reagent is contained in a bi-reagent cartridge.Reagent 1 contains water and a preservative. Reagent 2 containsphosphoenolpyruvate, nicotinamide adenine dinucleotide analog(reduced), phosphoenol pyruvate carboxylase, and malatedehydrogenase. |
|---|---|
| PerformanceData: | Performance data on the S-Test CO2 included precision, accuracy, andsensitivity data.Precision: In testing conducted at three CO2 levels for 21 days, thewithin-run CV ranged from 1.7 to 3.0%, and total CV ranged from 5.7to 6.7%. In precision studies at three separate Physician OfficeLaboratory (POL) sites and in-house over five or more days, thewithin-run CV ranged from 1.3 to 6.6% and total CV ranged from 2.0to 6.6%.Accuracy: In the correlation study, 94 samples with CO2 valuesranging from 6.0 to 41.8 mEq/L were assayed on the S40 ClinicalAnalyzer using S-Test CO2 and a comparison method. Least-squaresregression analysis yielded a correlation coefficient of 0.984, a standarderror estimate of 1.1, a confidence interval slope of 0.940 to 1.029, anda confidence interval intercept of -0.6 to 1.5. In patient correlationstudies at three separate POL sites using the S40 Clinical Analyzer anda comparative method, least-squares regression analysis yieldedcorrelation coefficients ranging from 0.937 to 0.980, standard errorestimates ranging from 1.40 to 2.65, confidence interval slopes rangingfrom 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. Thesedata also indicate substantial equivalence to the predicate devices. |
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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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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
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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
§ 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.