(307 days)
Not Found
No
The summary describes a standard photometric in vitro diagnostic test for calcium concentration, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an in vitro diagnostic (IVD) reagent intended for the quantitative determination of calcium concentration, which is used in diagnosis and treatment monitoring, not for direct therapeutic intervention.
Yes
The document explicitly states its intended use is for "diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany." It also mentions it is "For in vitro diagnostic use only."
No
The device 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:
- Intended Use/Indications for Use: Explicitly states "For in vitro diagnostic use only." and describes its use for the quantitative determination of calcium in serum or heparin plasma for the diagnosis and treatment of various diseases. This clearly indicates it's used to test samples taken from the body (in vitro) to aid in diagnosis.
- Device Description: Describes the reagent cartridge as being "intended for quantitative in vitro diagnostic determination of CA in serum or heparin plasma".
- Care Setting: Intended for use in "clinical laboratories or physician office laboratories," which are typical settings for IVD testing.
N/A
Intended Use / Indications for Use
The S-Test Calcium Reagent is intended for the quantitative determination of calcium concentration in serum or heparin plasma using the S40 Clinical Analyzer. 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). 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)
CJY
Device Description
The S-Test Calcium (CA) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of CA in serum or heparin plasma based on a photometric test measuring the formation of a reddish-purple complex under strong alkaline conditions.
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 CA included precision, accuracy, and sensitivity data.
Precision: In testing conducted at three CA levels for 21 days, the within-run CV ranged from 1.1 to 1.2%, and total CV ranged from 1.6 to 2.2%. In precision studies at three separate Physician Office Laboratory (POL) sites and in-house over five days, the within-run CV ranged from 0.4 to 3.9% and total CV ranged from 0.7 to 4.3%.
Accuracy: In the correlation study, 181 samples with CA values ranging from 2.4 to 14.5 mg/dL were assayed on the S40 Clinical Analyzer using S-Test CA and a comparison method. Least-squares regression analysis yielded a correlation coefficient of 0.978, a standard error estimate of 0.4, a confidence interval slope of 0.950 to 1.003, and a confidence interval intercept of -0.30 to 0.17. In patient correlation studies at four separate POL sites using the S40 Clinical Analyzer and a comparison method, least-squares regression analysis yielded a correlation coefficients in the range of 0.929 to 0.965, standard error estimates of 0.49 to 0.68, confidence interval slopes of 0.833 to 1.048, and confidence interval intercepts of -0.62 to 1.54.
Sensitivity: The detection limit was 2.3 mg/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision: within-run CV ranged from 1.1 to 1.2%, total CV ranged from 1.6 to 2.2%; in POL sites and in-house, within-run CV ranged from 0.4 to 3.9%, total CV ranged from 0.7 to 4.3%.
Accuracy: correlation coefficient of 0.978, standard error estimate of 0.4, confidence interval slope of 0.950 to 1.003, confidence interval intercept of -0.30 to 0.17. In POL sites, correlation coefficients in the range of 0.929 to 0.965, standard error estimates of 0.49 to 0.68, confidence interval slopes of 0.833 to 1.048, and confidence interval intercepts of -0.62 to 1.54.
Sensitivity: The detection limit was 2.3 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
§ 862.1145 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
510(k) SUMMARY
JUN 2 4 2008
| 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 CA Reagent cartridge |
| | Common/Classification Name: | Calcium Test System
(21 C.F.R. § 862.1145)
Product Code CJY |
| | Classification: | Class II |
| Predicate
Devices: | Manufacturers for analyzer/reagent system predicates are:
- ACE plus ISE/Clinical Chemistry System
ACE Calcium Reagent (K931786) - Ortho Clinical Diagnostics Fusion Clinical Chemistry Analyzer
Calcium Reagent (K946090) - Piccolo® xpress Chemistry Analyzer
Calcium Reagent (K942782) | |
| Device
Description: | The S-Test Calcium (CA) reagent cartridge, used with the S40 Clinical
Analyzer, is intended for quantitative in vitro diagnostic determination
of CA in serum or heparin plasma based on a photometric test
measuring the formation of a reddish-purple complex under strong
alkaline conditions. | |
| Intended Use: | The S-Test Calcium Reagent is intended for the quantitative
determination of calcium concentration in serum or heparin plasma
using the S40 Clinical Analyzer. 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). This test is intended for use in clinical
laboratories or physician office laboratories. For in vitro diagnostic use
only | |
| Technological
Characteristics: | The S-Test CA Reagent is contained in a bi-reagent cartridge. Reagent
1 contains monoethanolamine buffer and 8-hydroxyquinoline. Reagent
2 contains o-cresolphthalein complexone. | |
| Performance
Data: | Performance data on the S-Test CA included precision, accuracy, and
sensitivity data.
Precision: In testing conducted at three CA levels for 21 days, the
within-run CV ranged from 1.1 to 1.2%, and total CV ranged from 1.6
to 2.2%. In precision studies at three separate Physician Office
Laboratory (POL) sites and in-house over five days, the within-run CV
ranged from 0.4 to 3.9% and total CV ranged from 0.7 to 4.3%.
Accuracy: In the correlation study, 181 samples with CA values
ranging from 2.4 to 14.5 mg/dL were assayed on the S40 Clinical
Analyzer using S-Test CA and a comparison method. Least-squares
regression analysis yielded a correlation coefficient of 0.978, a standard
error estimate of 0.4, a confidence interval slope of 0.950 to 1.003, and
a confidence interval intercept of -0.30 to 0.17. In patient correlation
studies at four separate POL sites using the S40 Clinical Analyzer and a
comparison method, least-squares regression analysis yielded a
correlation coefficients in the range of 0.929 to 0.965, standard error
estimates of 0.49 to 0.68, confidence interval slopes of 0.833 to 1.048,
and confidence interval intercepts of -0.62 to 1.54.
Sensitivity: The detection limit was 2.3 mg/dL. | |
| 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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Public Health Service
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: K072356
Trade/Device Name: S Test Calcium Reagent cartridge Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY Dated: June 16, 2008 Received: June 17, 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).
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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.
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
4
Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K072356
S40 Clinical Analyzer S-Test CA
Indications for Use Statement
510(k) Number K072356 (if known):
Device Name:
S-Test Calcium (CA)
Indications for Use: The S-Test Calcium Reagent is intended for the quantitative determination of calcium concentration in serum or heparin plasma using the S40 Clinical Analyzer. 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). 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 Device Evaluation (OIVD) | |
|---|---|
| Division/Sign-Off |
Office of in Vitro Diagnostic
Device Evaluation and Safety
June 3, 2008
510(k) K072336
CONFIDENTIAL