(161 days)
Not Found
No
The description focuses on a photometric chemical reaction and does not mention any AI/ML components or algorithms.
No
This device is an in vitro diagnostic reagent system used for quantitative determination of calcium, which aids in diagnosis and treatment, but it is not a therapeutic device itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostics reagent system" and that "Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany." This indicates its role in diagnosing medical conditions.
No
The device is an in vitro diagnostic reagent system, which is a chemical substance used in a laboratory test, not a software-only device.
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 Calcium Gen.2 assay is an "in vitro diagnostics reagent system".
- Purpose: It is intended for the quantitative determination of calcium in human samples (serum, plasma, and urine), which is a diagnostic measurement used in the diagnosis and treatment of various diseases.
- Method: The "Device Description" describes a photometric test method performed on a laboratory system (Roche/Hitachi cobas c systems), which is a typical in vitro diagnostic process.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Calcium Gen.2 assay is an in vitro diagnostics reagent system intended for the quantitative determination of calcium in human serum, plasma, and urine on Roche/Hitachi cobas c systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany.
Product codes (comma separated list FDA assigned to the subject device)
CHW
Device Description
The Calcium Gen. 2 test system employs a photometric test method where calcium ions react with a calcium specific polyamino carboxylic acid under alkaline conditions to form a complex. This complex reacts in the second step with EDTA. The calcium concentration is directly proportional to the change in absorbance which is measured photometrically.
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
Children (0-10 days), Children (10 days -2 years), Children (2 years-12 years), Children (12-18 years), Adults (18-60 years), Adults (60-90 years), Adults (>90 years)
Intended User / Care Setting
Not Found
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)
Precision studies were conducted for both serum/plasma and urine samples.
Serum/plasma:
Human serum 1: 2.4 mg/dL Mean, 2.0% CV Repeatability, 2.5% CV Intermediate precision
Human serum 2: 10.2 mg/dL Mean, 0.8% CV Repeatability, 0.9% CV Intermediate precision
Human serum 3: 17.9 mg/dL Mean, 0.8% CV Repeatability, 0.9% CV Intermediate precision
Precinorm U: 9.0 mg/dL Mean, 0.8% CV Repeatability, 0.8% CV Intermediate precision
Precipath U: 14.1 mg/dL Mean, 0.8% CV Repeatability, 0.9% CV Intermediate precision
Urine:
Human urine 1: 2.3 mg/dL Mean, 3.0% CV Repeatability, 3.1% CV Intermediate precision
Human urine 2: 15.7 mg/dL Mean, 1.1% CV Repeatability, 1.2% CV Intermediate precision
Human urine 3: 20.8 mg/dL Mean, 0.9% CV Repeatability, 1.1% CV Intermediate precision
Human urine 4: 24.4 mg/dL Mean, 1.3% CV Repeatability, 1.3% CV Intermediate precision
Control Level 1: 7.4 mg/dL Mean, 1.3% CV Repeatability, 1.5% CV Intermediate precision
Control Level 2: 10.9 mg/dL Mean, 1.1% CV Repeatability, 1.3% CV Intermediate precision
Lower Limits of Measure:
Serum/Plasma: LoB: 0.4 mg/dL, LoD: 0.8 mg/dL, LoQ: 0.8 mg/dL
Urine: LoB: 0.4 mg/dL, LoD: 0.8 mg/dL, LoQ: 0.8 mg/dL
Measuring Range:
Serum/Plasma: 0.8 – 20.1 mg/dL
Urine: 0.8 – 30.1 mg/dL
Interference testing was also performed.
Serum/Plasma:
Endogenous Interferent Claims: No significant interference up to an I index of 60 (Icterus), no significant interference up to an H index of 1000 (Hemolysis), no significant interference up to an L index of 1000 (Lipemia).
Gadolinium containing MRI contrast media (Omniscan®, Optimark®) was tested; no interference found at therapeutic concentration for Omniscan® but interference at higher concentrations. For Optimark®, interference observed at therapeutic and higher concentrations.
In very rare cases, gammopathy, in particular type IgM (Waldenstrom's macroglulinemia), may cause unreliable results.
Urine:
Icterus: no significant interference up to a conjugated bilirubin concentration of 60 mg/dL
Hemolysis: no significant interference up to a hemoglobin concentration of 1000 mg/dL
Magnesium: no significant interference up to a concentration of 60 mmol/L
Drugs: No interference found at therapeutic concentrations using common drug panels.
Gadolinium containing MRI contrast media (Omniscan®, Optimark®) was tested; For Omniscan® no interference was observed at the therapeutic concentration, but there was interference at higher concentrations. For Optimark® interference was observed at therapeutic and higher concentrations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
MAY - 8 2012
510(k) Summary – Calcium Generation 2 Assay
| Introduction | Roche Diagnostics Corporation hereby submits this 510(k) to provide notification of our intent to market the Calcium Generation 2 assay. The original 510(k) summary was submitted by Kathie Goodwin on November 28, 2011. This revised version is a result of the changes that occurred based on Roche's hold response. |
|---|---|
| Submitter, name, address, contact | Roche Diagnostics |
| 9115 Hague Road | |
| PO Box 50416 | |
| Indianapolis, IN 46250 | |
| Phone: 317-521-1942 | |
| Fax: 317-521-2324 | |
| New Primary Contact person: Lisa Klinedinst | |
| Email: lisa.klinedinst@roche.com | |
| Date prepared: March 30, 2012 | |
| Device name | Proprietary name: Calcium Gen. 2 |
| Common name: CA2 | |
| Classification name: Calcium Test System under 21 CFR 862.1145 | |
| Product code: CHW | |
| Device description | The Calcium Gen. 2 test system employs a photometric test method where calcium ions react with a calcium specific polyamino carboxylic acid under alkaline conditions to form a complex. This complex reacts in the second step with EDTA. The calcium concentration is directly proportional to the change in absorbance which is measured photometrically. |
Continued on next page
1
510(k) Summary - Calcium Generation 2 Assay, continued
| Intended use | The Calcium Gen.2 assay is an in vitro diagnostics reagent system
intended for quantitative determination of calcium in human serum,
plasma and urine on Roche/Hitachi cobas c systems. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate
device | Roche claims substantial equivalence to the currently marketed
Calcium test system cleared in K921661. |
The following table compares the features of the draft device with the Substantial equivalence predicate device.
| Feature | Predicate Device:
Calcium (K921661) | Draft Device:
Calcium Gen. 2 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | In vitro test for the quantitative
determination of calcium in
human serum, plasma and urine
on Roche automated clinical
chemistry analyzers. | same |
| Sample Types | Serum, Heparin Plasma, and Urine | Serum, Li-Heparin Plasma and
Urine |
| Instrument
Platform | Roche Hitachi analyzers | cobas c 501 analyzer |
| Calibrator | Calibrator f.a.s. | same |
| Calibration
Frequency | Every 3 days if the reagent bottles
are onboard the analyzer for more
than 3 days; after reagent bottle
change if the previous bottles were
onboard the analyzer for more than
3 days; after reagent lot change;
and as required following quality
control procedures | After reagent lot change and as
required following quality control
procedures. |
| Calibration
Mode | Two point linear | same |
| Feature | Predicate Device:
Calcium (K921661) | Draft Device:
Calcium Gen. 2 |
| Controls | • Preinorm U Plus
• Precipath U Plus
• Preinorm U
• Precipath U | • Preinorm U Plus
• Precipath U Plus
• Preinorm U
• Precipath U
• PreciControl ClinChem
Multi1
• PreciControl ClinChem
Multi2 |
| Reagent Active
Ingredients | o-Cresolphthalein complexone, 8-
hydroxyquinoline, HCl acid | 5-nitro-5'-methyl-BAPTA |
| Reagent
Stability | Unopened
15-25°C until expiration date
On-board in use
R1: 42 days
R2: 90 days | Unopened
2-8°C until expiration date
On-board in use
42 days |
| Measuring
Range | Serum/Plasma:
0.2 – 20 mg/dL
Urine:
0.48 – 48 mg/dL | Serum/Plasma:
0.8 – 20.1 mg/dL
Urine:
0.8 – 30.1 mg/dL |
| Lower Limits
of Measure | Not Established | Serum/Plasma
LoB: 0.4 mg/dL
LoD: 0.8 mg/dL
LoQ: 0.8 mg/dL
Urine
LoB: 0.4 mg/dL
LoD: 0.8 mg/dL
LoQ: 0.8 mg/dL |
Continued on next page
2
510(k) Summary - Calcium Generation 2 Assay, continued
Substantial equivalence (continued)
Continued on next page
3
510(k) Summary - Calcium Generation 2 Assay, conlinued
| Feature | Predicate Device:
Calcium (K921661) | | Draft Device:
Calcium Gen. 2 | | | | |
|--------------------|--------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------|---------------------|------------------------------|------|------|
| | Serum/plasma | | Serum/plasma | | | | |
| | Mean | CV
Repeatability | Mean | CV
Repeatability | CV
Intermediate precision | | |
| | Human
serum | $8.49$ mg/dL | 0.9% | Human
serum 1 | $2.4$ mg/dL | 2.0% | 2.5% |
| | Precitrol
N | $9.18$ mg/dL | 0.7% | Human
serum 2 | $10.2$ mg/dL | 0.8% | 0.9% |
| | Precitrol
A | $13.3$ mg/dL | 0.4% | Human
serum 3 | $17.9$ mg/dL | 0.8% | 0.9% |
| | | Mean | CV
Intermediate
precision | Precinorm
U | $9.0$ mg/dL | 0.8% | 0.8% |
| | Human
serum | $8.41$ mg/dL | 1.6% | Precipath
U | $14.1$ mg/dL | 0.8% | 0.9% |
| | Precitrol
N | $9.12$ mg/dL | 1.7% | | | | |
| Precision | Precitrol
A | $13.1$ mg/dL | 1.1% | | | | |
| | Urine | | Urine | | | | |
| | Mean | CV
Repeatability | Mean | CV
Repeatability | CV
Intermediate precision | | |
| | Human
urine | $14.3$ mg/dL | 0.8% | Human
urine 1 | $2.3$ mg/dL | 3.0% | 3.1% |
| | Control
Urine 1 | $6.12$ mg/dL | 1.2% | Human
urine 2 | $15.7$ mg/dL | 1.1% | 1.2% |
| | Control
Urine 2 | $10.8$ mg/dL | 0.9% | Human
urine 3 | $20.8$ mg/dL | 0.9% | 1.1% |
| | | Mean | CV
Intermediate
precision | Human
urine 4 | $24.4$ mg/dL | 1.3% | 1.3% |
| | Human
urine | $14.0$ mg/dL | 1.4% | Control
Level 1 | $7.4$ mg/dL | 1.3% | 1.5% |
| | Control
Urine 1 | $6.04$ mg/dL | 1.6% | Control
Level 2 | $10.9$ mg/dL | 1.1% | 1.3% |
| | Control
Urine 2 | $10.7$ mg/dL | 1.4% | | | | |
| | Serum/plasma:
8.6-10.2 mg/dL | | Reference range acc. To Tietz
Serum/plasma: | | | | |
| | 24 Hour Urine:
100-321 mg/24 h, corresponding to
6.8-21.3 mg/dL | | Children (0-10 days): 7.6-10.4 mg/dL | | | | |
| | Reference range acc. To Tietz
Serum/plasma: | | Children (10 days -2 years): 9.0-11.0 mg/dL | | | | |
| Expected
Values | Children (0-10 days): 7.6-10.4 mg/dL | | Children (2 years-12 years): 8.8-10.8 mg/dL | | | | |
| | Children (10 days -2 years): 9.0-11.0 mg/dL | | Children (12-18 years): 8.4-10.2 mg/dL | | | | |
| | Children (2 years-12 years): 8.8-10.8 mg/dL | | Adults (18-60 years): 8.6-10.0 mg/dL | | | | |
| | Children (12-18 years): 8.4-10.2 mg/dL
Adults (18-60 years): 8.6-10.0 mg/dL | | Adults (60-90 years): 8.8-10.2 mg/dL
Adults (>90 years): 8.2-9.6 mg/dL | | | | |
| | Adults (60-90 years): 8.8-10.2 mg/dL
Adults (>90 years): 8.2-9.6 mg/dL | | Urine
100-300 mg/24 h with normal
food intake | | | | |
| | Urine
100-300 mg/24 h with normal food
intake | | | | | | |
Substantial equivalence (continued)
Continued on next page
4
510(k) Summary - Calcium Generation 2 Assay, continued
Substantial equivalence (continued)
| Feature | Predicate Device:
Calcium (K921661) | Draft Device:
Calcium Gen. 2 |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Interferences | Serum/Plasma
Icterus:
no significant interference up to an I
index of 60
Hemolysis:
no significant interference up to and
H index of 1000
Lipemia:
no significant interference up to an L
index of 1000
Drugs:
Drugs containing strontium salts
may lead to significantly increased
calcium results.
Other:
-Intravenously administered contrast
media for MRI contain chelating
complexes which may interfere with
the determination of calcium.
-A sharp decrease in calcium values
was observed when gadodiamide
was administered. Follow the
instructions of the manufacturer with
regard to the retention time of the
contrast medium.
-In very rare cases gammopathy, in
particular type IgM (Waldenstrom's
macroglulinemia), may cause
unreliable results.
Urine:
Drugs: Drugs containing strontium
salts may lead to significantly
increased calcium results. | Serum/Plasma
Same Endogenous Interferent
Claims
And in Addition:
-The interference of intravenously
administered gadolinium containing
MRI (magnetic resonance imaging)
contrast media was tested (Omniscan®,
Optimark®) but no interference was
found at the therapeutic concentration.
Interference at higher concentrations was
observed.
-In very rare cases gammopathy, in
particular type IgM (Waldenstrom's
macroglulinemia), may cause unreliable
results.
Urine:
Icterus:
no significant interference up to a
conjugated bilirubin concentration of
60 mg/dL
Hemolysis:
no significant interference up to a
hemoglobin concentration of 1000
mg/dL
Magnesium:
no significant interference up to a
concentration of 60 mmol/L
Drugs:
No interference was found at
therapeutic concentrations using
common drug panels.
Other:
-The interference of intravenously
administered gadolinium containing
MRI (magnetic resonance imaging)
contrast media was tested (Omniscan®,
Optimark®). For Omniscan® no
interference was observed at the
therapeutic concentration, but there was
interference at higher concentrations.
For Optimark® interference was
observed at therapeutic and higher
concentrations. |
End of Summary
.
.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with flowing lines representing its wings or feathers.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Roche Diagnostics Operations, Inc. c/o Lisa Klinedinst 9115 Hague Road · P. O. Box 50416 Indianapolis, IN 46250
MAY - 8 2002
Re: K113521 Trade Name: Calcium Gen.2 Regulation Number: 21 CFR §862.1145 Regulation Name: Calcium Test System Regulatory Class: Class II Product Codes: CHW Dated: March 30, 2012 Received: April 2, 2012
Dear Ms. Klinedinst:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
6
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
signature
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
k 11352 510(k) Number (if known):
Device Name: Roche/Hitachi cobas c Calcium Gen.2
Indications For Use:
The Calcium Gen.2 assay is an in vitro diagnostics reagent system intended for the quantitative determination of calcium in human serum, plasma, and urine on Roche/Hitachi cobas c systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany.
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 Devices (OIVD)
Ruta Clim
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113521
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