(257 days)
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No
The device description and performance studies focus on a chemical reagent and its analytical performance on a specific laboratory system, with no mention of AI or ML.
No
The device is a reagent for diagnostic testing of calcium levels, not a therapeutic device designed to treat or alleviate diseases.
Yes
The device is intended for the quantitative determination of total calcium, which aids in the diagnosis of diseases associated with hypercalcemia and hypocalcemia, indicating a diagnostic purpose.
No
The device description clearly states it is a liquid reagent composed of chemical substances, which is a physical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of total calcium in serum, plasma and urine... to aid in the diagnosis of diseases associated with hypercalcemia and hypocalcemia." This clearly indicates the device is used to test samples taken from the human body for diagnostic purposes.
- Device Description: The description states it's a "liquid composed of Arsenazo III and buffer for the quantitative determination of Calcium in serum, plasma and urine". This describes a reagent used to perform a test on biological samples.
- Performance Studies: The document details performance studies like precision, linearity, sensitivity, analytical specificity, and patient comparison using serum, plasma, and urine specimens. These are all standard evaluations for IVD devices.
- Predicate Device: The mention of a predicate device (K941764; HICHEM Calcium Reagent for the CX3) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
GenChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of diseases associated with hypercalcemia and hypocalcemia.
Product codes
CJY
Device Description
GenChem's Calcium reagent is a liquid composed of Arsenazo III and buffer for the quantitative determination of Calcium in serum, plasma and urine on the Beckman Synchron CX3® System.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Precision/Reproducibility: Control sera and diluted urine pools were each assayed 3 times per day over 10 days on a SYNCHRON CX3® System. Estimates of within run and total imprecision were calculated as described in NCCLS publication EP3-T 8. Sample sizes were n=60 for each of the 5 samples (3 serum, 2 urine).
Linearity/assay reportable range: Linearity was performed according to NCCLS Guideline EP6-A. Commercially available linearity standards ranging from 0 to 15 mg/dL were analyzed in triplicate on the Beckman CX3® and the results analyzed by the Least Squares method. The results gave a slope of 0.911 with an intercept of 0.34, a standard error of estimate of 0.35 and r2 = 1.000.
Sensitivity: The sensitivity of this method is 0.1 mg/dL and was documented through the repetitive assay of a diluted serum control. The observed sensitivity limit, calculated as three standard deviations of a 21 replicate within run precision study, is 0.05 mg/dL and is below the claimed limit of 0.1 mg/dL.
Analytical Specificity: Determined according to NCCLS EP7-A. Hemoglobin levels up to 500 mg/dL, Bilirubin levels up to 20 mg/dL, and Lipemia levels up to 1800 mg/dL were tested and did not show any adverse effect on a stock sample with a calcium level of 9.4 mg/dL.
Patient Comparison: Serum, plasma, and urine specimens, collected from adult patients, ranging from 0 to 15.2 mg/dL were assayed for total calcium on a SYNCHRON CX3® System using GenChem and Beckman® calcium reagents. Results were compared by least squares linear regression. Sample sizes were N=82 for serum, N=84 for plasma, and N=76 for urine.
Key Metrics
Precision (SD and %CV) provided for Serum 1 (7.2 mean): Within Run SD 0.06, %CV 0.7; Total SD 0.10, %CV 1.4. Serum 2 (10.6 mean): Within Run SD 0.05, %CV 0.5; Total SD 0.09, %CV 0.9. Serum 3 (14.0 mean): Within Run SD 0.05, %CV 0.3; Total SD 0.09, %CV 0.6. Urine 1 (4.0 mean): Within Run SD 0.03, %CV 0.7; Total SD 0.16, %CV 4.1. Urine 2 (12.7 mean): Within Run SD 0.06, %CV 0.5; Total SD 0.13, %CV 1.0.
Linearity: slope of 0.911, intercept of 0.34, standard error of estimate of 0.35, r2 = 1.000.
Sensitivity: 0.1 mg/dL. Observed sensitivity limit: 0.05 mg/dL.
Patient Comparison:
Serum: Intercept -0.1, Slope 0.994, R2 Value 0.971, N 82, Range (mg/dL) 7.0 - 10.6.
Plasma: Intercept -0.1, Slope 0.973, R2 Value 0.980, N 84, Range (mg/dL) 7.4 - 10.5.
Urine: Intercept 0.1, Slope 0.999, R2 Value 0.999, N 76, Range (mg/dL) 0.4 - 15.2.
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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DEC 27 2004
510(k) SUMMARY K040972
1.0 Submitted By:
C.C. Allain, Ph.D. Chief Scientific Officer GenChem, Inc. 471 W. Lambert Road, Ste 107 Brea, CA 92821 Telephone: (714) 529-7125 FAX: (714) 529-3339
2.0 Date of Preparation: June 1, 2004
3.0 Regulatory Information:
- 3.1 Regulation section: 21 CFR § 862.1145 GenChem Calcium Reagent for the Beckman Synchron CX3 System.
- 3.2 Clasification : Class II
- 3.3 Product Code: CJY
- 3.4 Panel: Clinical Chemistry (75)
4.0 Device Description:
GenChem's Calcium reagent is a liquid composed of Arsenazo III and buffer for the quantitative determination of Calcium in serum, plasma and urine on the Beckman Synchron CX3® System.
5.0 Substantial Equivalence Information:
- a. Predicate Device Name: HICHEM Calcium Reagent for the CX3
- b. Predicate K Number: K941764
Comparison with Predicate: The two products have the same intended C. use, chemical principle, composition, analytical range and stability.
6.0 Performance Characteristics: All studies were performed on the Beckman CX3 Synchron Analyzer
- 6.1 Precision/Reproducibility:
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Control sera and diluted urine pools were each assayed 3 times per day over 10 days.on a SYNCHRON CX3® System. Estimates of within run and total imprecision were calculated as described in NCCLS publication EP3-T 8
Precision of Total Calcium Recoveries (mg/dL)
| Sample | n | mean | SD | %CV | SD | %CV |
|---|---|---|---|---|---|---|
| Serum 1 | 60 | 7.2 | 0.06 | 0.7 | 0.10 | 1.4 |
| Serum 2 | 60 | 10.6 | 0.05 | 0.5 | 0.09 | 0.9 |
| Serum 3 | 60 | 14.0 | 0.05 | 0.3 | 0.09 | 0.6 |
| Urine 1 | 60 | 4.0 | 0.03 | 0.7 | 0.16 | 4.1 |
| Urine 2 | 60 | 12.7 | 0.06 | 0.5 | 0.13 | 1.0 |
6.2 Linearity/assay reportable range:
Linearity was performed according to NCCLS Guideline EP6-A. Commercially available linearity standards ranging from 0 to 15 mg/dL were analyzed in triplicate on the Beckman CX3® and the results analyzed by the Least Squares method. The results gave a slope of 0.911 with an intercept of 0.34, a standard error of estimate of 0.35 and r2 = 1.000. Samples exceeding these limits should be diluted with normal saline and reanalyzed. Multiply the result by the appropriate dilution factor.
| Usable Range | |||
|---|---|---|---|
| Specimens | Range | Conventional Units | SI Units |
| All | Normal | 0.1 to 15 mg/dL | 0.5 – 3.75 mmol/L |
6.3 SENSITIVITY
The sensitivity of this method is 0.1 mg/dL and was documented through the repetitive assay of a diluted serum control. The observed sensitivity limit, calculated as three standard deviations of a 21 replicate within run precision study, is 0.05 mg/dL and is below the claimed limit of 0.1 mg/dL.
6.4 Analytical Specificity
Determined according to NCCLS EP7-A. Hemoglobin levels up to 500 mg/dL, Bilirubin levels up to 20 mg/dL, and Lipemia levels up to 1800 mg/dL were tested and did not show any adverse effect on a stock sample with a calcium level of 9.4 mg/dL. Stock solutions of the substance to be tested were prepared at 20x concentrations and 0.5 ml of this stock was placed in a 10 ml volumetric flask and made up to volume with the base pool. The control stock was prepared similarly but with water as the diluent.
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Heparin, Lithium Heparin Ammonium Heparin, and EDTA are acceptable anticoagulants.
7.0 Patient Comparison
Serum, plasma, and urine specimens, collected from adult patients, ranging from 0 to 15.2 mg/dL were assayed for total calcium on a SYNCHRON CX3® System using GenChem and Beckman® calcium reagents. Results were compared by least squares linear regression and the following statistics were obtained.
| VALUE | SERUM | PLASMA | URINE |
|---|---|---|---|
| Intercept | -0.1 | -0.1 | 0.1 |
| Slope | 0.994 | 0.973 | 0.999 |
| R2 Value | 0.971 | 0.980 | 0.999 |
| N | 82 | 84 | 76 |
| Range (mg/dL) | 7.0 - 10.6 | 7.4 - 10.5 | 0.4 - 15.2 |
8.0 Expected Values/ Reference Range:
The expected values for total calcium are listed below. Use these ranges only as guides. Each laboratory should establish its own normal ranges.
Normal Ranges
| Specimens | Conventional Units | SI Units |
|---|---|---|
| Serum/Plasma | 8.4 - 10.2 mg/dL | 2.10 - 2.55 mmol/L |
| Urine | 100 - 300 mg/day | 2.5 - 7.5 mmol/day |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle or a bird in flight, composed of three stylized human profiles facing right. The profiles are stacked vertically, creating a sense of depth and unity.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 27 2004
C.C. Allain, Ph.D. Chief Scientific Officer GenChem, Inc. 471 W. Lambert Road, Suite 107 Brea, CA 92821
Re: K040972
Trade/Device Name: GenChem Calcium, Azo Dye Reagent Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY Dated: October 15, 2004 Received: October 15, 2004
Dear Dr. Allain:
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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Sincerely, yours,
Cornelia B. Lorks
Cornelia B. Rooks, MA Acting 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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INDICATIONS FOR USE
510(k) Number: K040972
Device Name: GenChem Calcium, Azo Dye Reagent
Indications For Use:
GenChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of diseases associated with hypercalcemia and hypocalcemia.
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ AND/OR Prescription Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Albert Satz
Division Sign-Off
Office of In Vitro Diagr Device Evaluation:
5100k K040972