(176 days)
HiChem" Calcium Reagent Kit, product no. 88815
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No
The summary describes a standard in vitro diagnostic reagent kit and chemistry system for measuring calcium levels, relying on chemical reactions and absorbance measurements, with no mention of AI/ML components or data training/testing.
No
Explanation: The device is an in vitro diagnostic reagent kit and system that quantitatively measures calcium in serum and plasma. It provides information for diagnosis and treatment, but it does not directly perform or provide a therapeutic effect on the patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Calcium results are for the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany (intermittent muscular contractions or spasms)." This indicates the device is used to diagnose medical conditions.
No
The device is a reagent kit and a chemistry system, which are physical components used in an in vitro diagnostic process, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is "intended for use as a system for the quantitation of calcium in serum and plasma." This is a classic description of an in vitro diagnostic test, as it involves analyzing biological samples (serum and plasma) outside of the body.
- Purpose of Results: The intended use also states that the calcium results are "for the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany." This clearly indicates that the results are used for medical purposes related to diagnosis and treatment, which is a key characteristic of an IVD.
- Device Description: The "Device Description" further clarifies that the reagent kit is for the "quantitative determination of calcium in serum and plasma" and that the results are for the "diagnosis and treathyroid disease, a variety of bone diseases, chronic renal disease and tetany." This reinforces the IVD nature of the device.
- Sample Type: The device analyzes serum and plasma, which are biological specimens.
- Methodology: The description of the method (binding by o-cresolphthalein complexone at alkaline pH and measuring absorbance) is consistent with an in vitro chemical assay.
- Performance Studies: The inclusion of performance studies like linearity, precision, and method comparison are standard for demonstrating the analytical performance of an IVD.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (which is associated with FDA submissions for medical devices, including IVDs) further confirms its classification as a medical device, specifically an IVD in this context.
Therefore, based on the provided information, the ATAC Calcium Reagent Kit, ATAC Calibrator, and ATAC 8000 Random Access Chemistry System are intended to be used as an In Vitro Diagnostic system.
N/A
Intended Use / Indications for Use
The ATAC Calcium Reagent Kit is intended for the quantitative determination of calcium in serum and plasma. Calcium results are for the diagnosis and treathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The ATAC Calcium Reagent determines calcium through binding by o-cresolphthalein complexone at alkaline pH. The resulting increase in absorbance at 578 nm is proportion al to the calcium concentration of the sample.
The ATAC Calcium Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitation of calcium in serum and plasma. Calcium results are for the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany (intermittent muscular contractions and spasms).
Product codes
CIC
Device Description
The ATAC Calcium Reagent Kit determines calcium through binding by o-cresolphthalein complexone at alkaline pH. The resulting increase in absorbance at 578 nm is proportion al to the calcium concentration of the sample.
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
adult patients
Intended User / Care Setting
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
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
The effectiveness of ATAC Calcium Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.
The recovery of calcium using the ATAC Calcium Reagent is linear from 0.2 to 15 mg/dL, as shown by the recovery of linearity standards that span the usable range. Regression statistics, which are forced through the origin, compare standard recoveries to standard values. These statistics are shown below.
r = 0.9984, (ATAC Recoveries) = 1.069 x (Standard Value), sy.x = 0.32 mg/dL, n = 21
Precision is demonstrated by the replicate assay of commercially available control serum on two separate instruments, Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.
Mixed serum and plasma specimens, collected from adult patients, were assayed for calcium using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by least squares linear regression and the following statistics were obtained.
ATAC 8000 = 0.7 mg/dL + 0.944 x Competitive Reagent r = 0.942 n = 120 range = 6.4 - 11.5 mg/dL
The detection limit of 0.2 mg/dL is documented through the repetitive assay of a diluted serum pool. The observed standard deviation of a 30 replicate within run precision study was 0.05 mg/dL. Consequently, the detection limit is reported as twice the round-off error of the assay.
The 14 day on board reagent stability and 4 hour calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, the total imprecision of calcium recoveries over the test than 0.2 mg/dL or 2%.
Key Metrics
-Recovery of calcium linear from 0.2 to 15 mg/dL.
r = 0.9984
sy.x = 0.32 mg/dL
n = 21
-Precision:
Serum 1: n=60, mean=7.4, Within Run 1SD=0.11, %CV=1.4%, Total 1SD=0.14, %CV=1.9%
Serum 2: n=60, mean=10.4, Within Run 1SD=0.20, %CV=1.9%, Total 1SD=0.21, %CV=2.0%
Serum 3: n=60, mean=13.2, Within Run 1SD=0.17, %CV=1.3%, Total 1SD=0.23, %CV=1.8%
-Comparison with Competitive Reagent:
ATAC 8000 = 0.7 mg/dL + 0.944 x Competitive Reagent
r = 0.942
n = 120
range = 6.4 - 11.5 mg/dL
-Detection limit: 0.2 mg/dL (based on 2x standard deviation of 0.05 mg/dL from 30 replicate within run precision study).
Predicate Device(s)
HiChem" Calcium Reagent Kit, product no. 88815
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K023/05
MAR 1 3 2003
Image /page/0/Picture/2 description: The image shows the word "élan" in a stylized font. The "é" has a unique design, with the top half of the letter being a solid black circle and the bottom half being a white circle. Above the "é" is a black parallelogram with a textured pattern. The rest of the word "lan" is written in a cursive font.
1075 W. Lambert Road Building D Brea, California 92821 T (714) 672 3553 F (714) 672 3554
SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The ATAC Calcium Reagent Kit is intended for the quantitative determination of calcium in serum and plasma. Calcium results are for the diagnosis and treathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The ATAC Calcium Reagent determines calcium through binding by o-cresolphthalein complexone at alkaline pH. The resulting increase in absorbance at 578 nm is proportion al to the calcium concentration of the sample.
The ATAC Calcium Reagent Kit is substantially equivalent to the HiChem" Calcium Reagent Kit, product no. 88815, which is marketed by Elan Inc. of Brea California. The effectiveness of ATAC Calcium Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.
The recovery of calcium using the ATAC Calcium Reagent is linear from 0.2 to 15 mg/dL, as shown by the recovery of linearity standards that span the usable range. Regression statistics, which are forced through the origin, compare standard recoveries to standard values. These statistics are shown below.
r = 0.9984, (ATAC Recoveries) = 1.069 x (Standard Value), sy.x = 0.32 mg/dL, n = 21
Precision is demonstrated by the replicate assay of commercially available control serum on two separate instruments, Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.
| Sample | n | mean | Within Run | Total | ||
|---|---|---|---|---|---|---|
| 1SD | %CV | 1SD | %CV | |||
| Serum 1 | 60 | 7.4 | 0.11 | 1.4% | 0.14 | 1.9% |
| Serum 2 | 60 | 10.4 | 0.20 | 1.9% | 0.21 | 2.0% |
| Serum 3 | 60 | 13.2 | 0.17 | 1.3% | 0.23 | 1.8% |
Mixed serum and plasma specimens, collected from adult patients, were assayed for calcium using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by least squares linear regression and the following statistics were obtained.
ATAC 8000 = 0.7 mg/dL + 0.944 x Competitive Reagent r = 0.942 n = 120 range = 6.4 - 11.5 mg/dL
The detection limit of 0.2 mg/dL is documented through the repetitive assay of a diluted serum pool. The observed standard deviation of a 30 replicate within run precision study was 0.05 mg/dL. Consequently, the detection limit is reported as twice the round-off error of the assay.
The 14 day on board reagent stability and 4 hour calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, the total imprecision of calcium recoveries over the test than 0.2 mg/dL or 2%.
Wynn Staley
Wynn Stocking Manager of Regulatory Affairs Elan
510(k) Notification, ATAC Calcium Reagent Kit, 17 September, 2002, p 49
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Wynn Stocking Regulatory Affairs Manager Elan Diagnostics 1075 W. Lambert Road Building D Brea, CA 92821
MAR 1 3 2003
Re: K023105
Trade/Device Name: ATAC Calcium Reagent Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CIC Dated: January 21, 2003 Received: January 22, 2003
Dear Mr. Stocking:
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 yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name:
ATAC Calcium Reagent
Indications for Use:
The ATAC Calcium Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitation of calcium in serum and plasma. Calcium results are for the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany (intermittent muscular contractions or spasms).
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jean Cooper
(Division Sign-Off) Division of Clinical Laboratory De 510(k) Number .
Prescription Use L (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)