(327 days)
Not Found
No
The summary describes a photometric assay for measuring chemical concentrations and does not mention any AI/ML components or related concepts like training/test sets.
No.
This device is an in vitro diagnostic (IVD) reagent intended for the quantitative determination of inorganic phosphorous and uric acid concentrations in serum or plasma. It is used to aid in the diagnosis and treatment of various disorders, but it does not directly treat or prevent a disease; rather, it provides information for diagnostic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements obtained from this device are "used in the diagnosis and treatment of various disorders." Additionally, the product is indicated for "For in vitro diagnostic use only," further confirming its diagnostic purpose.
No
The device described is a reagent cartridge used with a clinical analyzer, which are physical components, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for both the S-Test Inorganic Phosphorous Reagent and the S-Test Uric Acid Reagent explicitly states: "For in vitro diagnostic use only."
- Intended Use: The intended use is to quantitatively determine the concentration of inorganic phosphorous and uric acid in serum or heparin plasma. These are biological samples taken from the body, and the analysis is performed outside of the body (in vitro).
- Purpose: The measurements are used in the diagnosis and treatment of various disorders. This is a key characteristic of IVD devices.
- Device Description: The device description further clarifies that the reagents are intended for quantitative in vitro diagnostic determination.
- Care Setting: The intended users are 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 Inorganic Phosphorous Reagent is intended for the quantitative determination of inorganic phosphorous concentration in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum or heparin plasma using the S40 Clinical Analyzer. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. 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)
CEO, KNK
Device Description
The S-Test inorganic phosphorus (IP) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of IP in serum or heparin plasma based on a photometric test measuring the formation of molybdenum blue from IP and ammonium molybdate.
The S-Test uric acid (UA) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of UA in serum or heparin plasma based on a photometric test measuring the formation of a reddish-purple pigment.
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 IP and S-Test UA included precision, accuracy, and sensitivity data.
S-Test IP
Precision: In testing conducted at three IP levels for 22 days, the within-run CV ranged from 1.5 to 2.9%, and total CV ranged from 2.6 to 4.0%. In precision studies at three separate Physician Office Laboratory (POL) sites and in-house over five days, the within-run CV ranged from 0.9 to 3.4% and the total CV ranged from 1.2 to 3.4%.
Accuracy: In the correlation study, 95 samples with IP values ranging from 1.1 to 8.9 mg/dL were assayed on the S40 Clinical Analyzer using S-Test IP and a comparison method. Least-squares regression analysis yielded a correlation coefficient of 0.976, a standard error estimate of 0.3, a confidence interval slope of 1.026 to 1.150, and a confidence interval intercept of -0.03 to 0.34. In patient correlation studies at three separate POL sites using the S40 Clinical Analyzer and a comparison method, least-squares regression analysis yielded correlation coefficients ranging from 0.992 to 0.998, standard error estimates of 0.10 to 0.21, confidence interval slopes of 1.002 to 1.173, and a confidence interval intercept of -0.075 to 0.395.
Sensitivity: The detection limit was 1.2 mg/dL.
S-Test UA
Precision: In testing conducted at three UA levels for 22 days, the within-run CV ranged from 0.9 to 2.1%, and total CV ranged from 3.1 to 3.5%. In precision studies at three separate POL sites and in-house over five days, the within-run CV ranged from 0.3 to 2.2% and total CV ranged from 0.7 to 2.3%.
Accuracy: In the correlation study, 183 samples with UA values ranging from 2.9 to 20.2 mg/dL were assayed on the S40 Clinical Analyzer using S-Test UA and a comparison method. Least-squares regression analysis yielded a correlation coefficient of 0.974, a standard error estimate of 0.7, a confidence interval slope of 1.003 to 1.087, and a confidence interval intercept of -1.03 to -0.49. In patient correlation studies at three separate POL sites using the S40 Clinical Analyzer and a comparison method, least-squares regression analysis yielded correlation coefficients ranging from 0.967 to 0.995, standard error estimates of 0.32 to 0.69, confidence interval slopes of 0.968 to 1.202, and a confidence interval intercept of -1.400 to 0.469.
Sensitivity: The detection limit was 1.4 mg/dL.
Based on the foregoing data, the device is safe and effective. These data also indicate substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
S-Test IP: Sensitivity (detection limit) was 1.2 mg/dL.
S-Test UA: Sensitivity (detection limit) was 1.4 mg/dL.
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
§ 862.1580 Phosphorus (inorganic) test system.
(a)
Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
JUN 2 4 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 IP; S-Test UA Reagent cartridge
(21 C.F.R. § 862.1580, Product code CEO; 21
C.F.R. § 862.1775, Product code KNK |
| | Classification | Class I (reserved) |
| | Common/Classification Name: | Inorganic phosphorus; uric acid test systems |
| Predicate Devices: | | Manufacturers for analyzer/reagent system predicates are: |
| | 1. | ACE plus ISE/Clinical Chemistry System
ACE Inorganic Phosphorous Reagent (K931786)
ACE Uric Acid Reagent (K931786) |
| | 2. | Olympus AU640 Clinical Chemistry Analyzer
Inorganic Phosphorous Reagent (K961274)
Uric Acid Reagent (K961274) |
| | 3. | Piccolo® xpress Chemistry Analyzer
Inorganic Phosphorous Reagent (K942782)
Uric Acid Reagent (K942782) |
| Device Description: | | The S-Test inorganic phosphorus (IP) reagent cartridge, used with the S40
Clinical Analyzer, is intended for quantitative in vitro diagnostic determination
of IP in serum or heparin plasma based on a photometric test measuring the
formation of molybdenum blue from IP and ammonium molybdate.
The S-Test uric acid (UA) reagent cartridge, used with the S40 Clinical
Analyzer, is intended for quantitative in vitro diagnostic determination of UA
in serum or heparin plasma based on a photometric test measuring the
formation of a reddish-purple pigment. |
| Intended Use: | The S-Test Inorganic Phosphorous Reagent is intended for the quantitative
determination of inorganic phosphorous concentration in serum or heparin
plasma using the S40 Clinical Analyzer. Measurements of phosphorus
(inorganic) are used in the diagnosis and treatment of various disorders,
including parathyroid gland and kidney diseases, and vitamin D imbalance.
This test is intended for use in clinical laboratories or physician office
laboratories. For in vitro diagnostic use only.
The S-Test Uric Acid Reagent is intended for the quantitative determination of
uric acid concentration in serum or heparin plasma using the S40 Clinical
Analyzer. Uric acid measurements are used in the diagnosis and treatment of
numerous renal and metabolic disorders, including renal failure, gout,
leukemia, psoriasis, starvation or other wasting conditions, and of patients
receiving cytotoxic drugs. This test is intended for use in clinical laboratories
or physician office laboratories. For in vitro diagnostic use only. | |
| Technological
Characteristics: | The S-Test IP is a bi-reagent cartridge. Reagent 1 contains p-
methylaminophenol sulfate and nonionic surface-active agent. Reagent 2
contains ammonium molybdate and sulfuric acid.
The S-Test UA is a bi-reagent cartridge. Reagent 1 contains N-ethyl-N-(2-
hydroxy-3-sulfopropyl)-m-toluidine sodium salt (TOOS), peroxidase, and 2-
(N-morpholino) ethanesulfonic acid buffer (pH 6.9). Reagent 2 contains
uricase (derived from yeast), 4-aminoantipyrine, and 2-(N-morpholino)
ethanesulfonic acid buffer (pH 6.9). | |
| Performance
Data: | Performance data on the S-Test IP and S-Test UA included precision,
accuracy, and sensitivity data.
S-Test IP
Precision: In testing conducted at three IP levels for 22 days, the within-run
CV ranged from 1.5 to 2.9%, and total CV ranged from 2.6 to 4.0%. In
precision studies at three separate Physician Office Laboratory (POL) sites and
in-house over five days, the within-run CV ranged from 0.9 to 3.4% and the
total CV ranged from 1.2 to 3.4%.
Accuracy: In the correlation study, 95 samples with IP values ranging from
1.1 to 8.9 mg/dL were assayed on the S40 Clinical Analyzer using S-Test IP
and a comparison method. Least-squares regression analysis yielded a
correlation coefficient of 0.976, a standard error estimate of 0.3, a confidence
interval slope of 1.026 to 1.150, and a confidence interval intercept of -0.03 to
0.34. In patient correlation studies at three separate POL sites using the S40
Clinical Analyzer and a comparison method, least-squares regression analysis
yielded correlation coefficients ranging from 0.992 to 0.998, standard error
estimates of 0.10 to 0.21, confidence interval slopes of 1.002 to 1.173, and a
confidence interval intercept of -0.075 to 0.395.
Sensitivity: The detection limit was 1.2 mg/dL. | |
| | S-Test UA | |
| | Precision: In testing conducted at three UA levels for 22 days, the within-run
CV ranged from 0.9 to 2.1%, and total CV ranged from 3.1 to 3.5%. In
precision studies at three separate POL sites and in-house over five days, the
within-run CV ranged from 0.3 to 2.2% and total CV ranged from 0.7 to 2.3%. | |
| | Accuracy: In the correlation study, 183 samples with UA values ranging from
2.9 to 20.2 mg/dL were assayed on the S40 Clinical Analyzer using S-Test UA
and a comparison method. Least-squares regression analysis yielded a
correlation coefficient of 0.974, a standard error estimate of 0.7, a confidence
interval slope of 1.003 to 1.087, and a confidence interval intercept of -1.03 to
-0.49. In patient correlation studies at three separate POL sites using the S40
Clinical Analyzer and a comparison method, least-squares regression analysis
yielded correlation coefficients ranging from 0.967 to 0.995, standard error
estimates of 0.32 to 0.69, confidence interval slopes of 0.968 to 1.202, and a
confidence interval intercept of -1.400 to 0.469. | |
| | Sensitivity: The detection limit was 1.4 mg/dL. | |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These data also
indicate substantial equivalence to the predicate devices. | |
1
·
2
:
.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The text is in all caps and is written in a sans-serif font. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 4 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: K072141
Trade/Device Name: S Test Inorganic Phosphorous (IP) Reagent cartridge and S Test Uric Acid (UA) Reagent cartridge Regulation Number: 21 CFR 862.1580 Regulation Name: Phosphorous (inorganic) test system Regulatory Class: Class I, reserved
Product Code: CEO, KNK Dated: June 18, 2008
Received: June 19, 2008
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).
4
Pagc 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.
Yean 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
5
Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K072141
S40 Clinical Analyzer S-Test IP S-Test UA
Indications for Use
510(k) Number (if known):
S-Test Inorganic Phosphorus (IP) Devicc Name:
Indications for Use:
The S-Test Inorganic Phosphorous Reagent is intended for the quantitative determination of inorganic phosphorous concentration in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 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 |
Office of In Vitro Diagnostic CONFIDENTIA Device Evaluation and Safety
510(k) K072141
June 3, 2008
6
Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K072141
S40 Clinical Analyzer S-Test IP S-Test UA
Indications for Use
K072141 510(k) Number (if known):
Device Name: S-Test Uric Acid (UA)
Indications for Use: The S-Test Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum or heparin plasma using the S40 Clinical Analyzer. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
·
Over-The-Counter Use (21 CFR 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)
June 3, 2008
CONFIDENTIAL