(308 days)
No
The description details a standard immunoassay using competitive binding and calibration curves, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is described as an "in vitro diagnostic" device, used to measure folate levels for diagnosis and treatment planning, rather than directly providing therapy.
Yes
The document explicitly states that the "Measurements obtained by these devices are used in the diagnosis and treatment of anemias," which directly indicates their diagnostic purpose.
No
The device description clearly outlines physical components (reagents, calibrators, controls) and their use with immunoassay analyzers, indicating it is not a software-only device.
Based on the provided information, all of the listed devices are IVDs (In Vitro Diagnostics).
Here's why:
- Explicit Statement: The intended use for devices (1) and (2) explicitly states "For in vitro diagnostic use."
- Intended Use: All devices are intended for use in the quantitative determination of folate in human samples (serum, plasma, or erythrocytes). This measurement is used in the "diagnosis and treatment of anemias." This directly aligns with the definition of an IVD, which is a device intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease.
- Device Description: The descriptions detail how the devices analyze biological samples (human serum, plasma, whole blood) to measure an analyte (folate) relevant to a medical condition (anemia).
- Components of an IVD System: Devices (3), (4), and (5) are calibrators and controls. These are essential components of an IVD system, used to ensure the accuracy and reliability of the diagnostic test (the Elecsys Folate III assay). While not the primary assay themselves, they are integral to the diagnostic process.
Therefore, all five devices are considered IVDs.
N/A
Intended Use / Indications for Use
Folate III:
Binding assay for the in vitro quantitative determination of folate in human serum. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers.
RBC Folate Hemolyzing Reagent:
Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys Folate III assay for the quantitative determination of folate in erythrocytes (RBC (red blood cell) folate). Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers.
Folate III CalSet:
Elecsys Folate III CalSet is used for calibrating the quantitative Elecsys Folate III assay on the Elecsys and cobas e immunoassay analyzers.
Folate III CalCheck:
Elecsys Folate III CalCheck is used for the verification of the calibration established by the Elecsys Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.
PreciControl Anemia:
Elecsys PreciControl Anemia is used for the quality control of Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.
Indications for Use:
Folate III and RBC Folate Hemolyzing Reagent: Measurements obtained by these devices are used in the diagnosis and treatment of anemias.
Folate III CalSet: Elecsys Folate III CalSet is used for calibrating the quantitative Elecsys Folate III assay on the Elecsys and cobas e immunoassay analyzers.
Folate III CalCheck: Elecsys Folate III CalCheck is used for the verification of the calibration established by the Elecsys Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.
PreciControl Anemia: Elecsys PreciControl Anemia is used for the quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.
Product codes
CGN, JIT, JJX, JJY
Device Description
(1) The Elecsys Folate III assay employs a competitive test principle using natural folate binding protein (FBP) specific for folate. Folate in the sample competes with the added folate (labeled with biotin) for the binding sites on FBP (labeled with ruthenium complex). Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.
(2) The Elecsys RBC Folate Hemolyzing Reagent is a 0.2% ascorbic acid solution with which whole blood treated with anticoagulants (heparin or EDTA) is diluted. After incubation the erythrocytes are lysed and intracellular folate is liberated and stabilized. The hemolysate is then used as a prediluted sample for subsequent measurement in the Elecsys Folate III assay.
(3) The Elecsys Folate III CalSet is a lyophilized product consisting of human serum with folic acid in two concentration ranges. During manufacture, the analyte is spiked into the matrix. This calibrator is used to calibrate the Elecsys Folate III assay.
(4) Elecsys Folate III CalCheck is a lyophilized product consisting of human serum with folic acid. During manufacture, the analyte is spiked into the matrix. This solution is used to verify the calibration established with the Elecsys Folate III CalSet.
(5) The Elecsys PreciControl Anemia is a lyophilized control serum based on human serum matrix in three concentration ranges. The controls are used for monitoring the accuracy and precision of the Elecsys Ferritin, Folate III, and Vitamin B12 immunoassays.
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
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)
Method Comparison (Elecsys Folate III assay vs. Elecsys Folate II assay):
- Sample size: N=98
- Sample concentrations: between approx. 1.76 and 15.9 ng/mL
- Passing/Bablock: Slope = 1.13, Y intercept = -0.10, tau = 0.833
- Linear Regression: Slope = 1.13, Y intercept = -0.06, r=0.962
Method Comparison (Elecsys RBC Folate with Elecsys Folate III assay vs. Elecsys RBC Folate with Elecsys Folate II assay):
- Sample size: N=98
- Sample concentrations: between approx. 123 and 566 ng/mL
- Passing/Bablock: Slope = 1.096, tau = 0.700
- Linear Regression: Slope = 1.019, r = 0.921
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Elecsys Folate III Reagent:
- Measuring Range: 1.5 - 20.0 ng/mL
- Precision (Elecsys 2010 and cobas e411 Total Precision): PreciControl Anemia 2: SD 0.467 ng/mL; CV 6.4%, PreciControl Anemia 3: SD 0.986 ng/mL; CV 6.3%, Human Samples 10 ng/mL, CV 5.0%
- Analytical Sensitivity: Limit of Blank =
§ 862.1295 Folic acid test system.
(a)
Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.(b)
Classification. Class II.
0
510(k) Summary
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter name, address, contact
Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 (317) 521 - 3723
JUN 19 2009
Contact Person: Kathie J. Goodwin
Date Prepared: July 25, 2008
| Device Name | ||
|---|---|---|
Proprietary names: (1) Elecsys Folate III
(2) Elecsys RBC Folate Hemolyzing Reagent
(3) Elecsys Folate III CalSet
(4) Elecsys Folate III CalCheck
(5) Elecsys PreciControl Anemia
Common names:
(1) Folate III
(2) RBC Folate
(3) Folate III CalSet
(4) Folate III CalCheck
(5) PreciControl Anemia
Classification names: (1) Folic Acid Test System
(2) Folic Acid Test System
(3) Calibrator
(4) Quality Control Material (Assayed and Unassayed)
(5) Quality Control Material (Assayed and Unassayed)
Product codes: (1) CGN
| (2) | CGN |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
(3) JIT
- (4) JJX
- (5) JJY
1
(1) The Elecsys Folate III assay employs a competitive test principle using Description natural folate binding protein (FBP) specific for folate. Folate in the sample competes with the added folate (labeled with biotin) for the binding sites on FBP (labeled with ruthenium complex). Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.
(2) The Elecsys RBC Folate Hemolyzing Reagent is a 0.2% ascorbic acid solution with which whole blood treated with anticoagulants (heparin or EDTA) is diluted. After incubation the erythrocytes are lysed and intracellular folate is liberated and stabilized. The hemolysate is then used as a prediluted sample for subsequent measurement in the Elecsys Folate III assay.
(3) The Elecsys Folate III CalSet is a lyophilized product consisting of human serum with folic acid in two concentration ranges. During manufacture, the analyte is spiked into the matrix. This calibrator is used to calibrate the Elecsys Folate III assay.
(4) Elecsys Folate III CalCheck is a lyophilized product consisting of human serum with folic acid. During manufacture, the analyte is spiked into the matrix. This solution is used to verify the calibration established with the Elecsys Folate III CalSet.
(5) The Elecsys PreciControl Anemia is a lyophilized control serum based on human serum matrix in three concentration ranges. The controls are used for monitoring the accuracy and precision of the Elecsys Ferritin, Folate III, and Vitamin B12 immunoassays.
Device
2
Intended use Folate III:
Binding assay for the in vitro quantitative determination of folate in human serum. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers.
RBC Folate Hemolyzing Reagent:
Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys Folate III assay for the quantitative determination of folate in erythrocytes (RBC (red blood cell) folate). Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers.
Folate III CalSet:
Elecsys Folate III CalSet is used for calibrating the quantitative Elecsys Folate III assay on the Elecsys and cobas e immunoassay analyzers.
Folate III CalCheck:
Elecsys Folate III CalCheck is used for the verification of the calibration established by the Elecsys Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.
PreciControl Anemia:
Elecsys PreciControl Anemia is used for the quality control of Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.
Folate III and RBC Folate Hemolyzing Reagent: Measurements obtained Indications for Use by these devices are used in the diagnosis and treatment of anemias.
Folate III CalSet: Elecsys Folate III CalSet is used for calibrating the quantitative Elecsys Folate III assay on the Elecsys and cobas e immunoassay analyzers.
Folate III CalCheck: Elecsys Folate III CalCheck is used for the verification of the calibration established by the Elecsys Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.
PreciControl Anemia: Elecsys PreciControl Anemia is used for the quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.
3
Substantial The Elecsys Folate III Test System is substantially equivalent to the Elecsys equivalence Folate II Test System. This test system includes the following 5 components which have been cleared under the following K numbers:
-
- Elecsys Folate II (K043318)
-
- Elecsys RBC Hemolyzing Reagent (K051292)
-
- Elecsys Folate II CalSet II (K042490)
-
- Elecsys Folate II CalCheck II (K043320)
-
- Elecsys PreciControl Anemia (K051517)
(The original Elecsys Folate Assay was cleared under K973674.)
4
510(k) Summary, Continued
Substantial
equivalence comparison
| Elecsys Folate III Reagent | ||
|---|---|---|
| Feature | Elecsys Folate III Assay | Predicate Device: Elecsys Folate II |
| Assay (K043318) | ||
| Intended Use | Binding assay for the in vitro | |
| quantitative determination of | ||
| folate in human serum. The | ||
| binding assay is intended for use | ||
| on Elecsys and cobas e | ||
| immunoassay analyzers. | Binding assay for the in vitro | |
| quantitative determination of folate in | ||
| human serum. The binding assay is | ||
| intended for use on Elecsys and cobas e | ||
| immunoassay analyzers. | ||
| Indication for | ||
| Use | This assay may be used as an aid | |
| in the diagnosis and treatment of | ||
| anemias. | This assay may be used as an aid in the | |
| diagnosis and treatment of anemias. | ||
| Assay Protocol | Electrochemiluminescent | |
| Immunoassay | Electrochemiluminescent Immunoassay | |
| Sample Type | Serum (tubes containing | |
| separating gel can be used) | Serum (tubes containing separating gel | |
| can be used) | ||
| Labeled | ||
| Instrument | ||
| Platform | Roche Elecsys 2010/ cobas e 411 | |
| and MODULAR ANALYTICS | ||
| E170 (Elecsys module)/ cobas e | ||
| 601 analyzers. | Roche Elecsys 2010/ cobas e 411 and | |
| MODULAR ANALYTICS E170 | ||
| (Elecsys module)/ cobas e 601 | ||
| analyzers. | ||
| Calibrator | Elecsys Folate III CalSet | Elecsys Folate II CalSet II |
| Calibration | ||
| frequency | Once per reagent lot and | |
| After 1 month when using | ||
| same reagent lotAfter 7 days when using same | ||
| reagent kitAs required per QC findings or | ||
| pertinent regulations | Once per reagent lot and | |
| After 1 month when using same | ||
| reagent lotAfter 7 days when using same | ||
| reagent kitAs required per QC findings or | ||
| pertinent regulations | ||
| Controls | PreciControl Anemia | PreciControl Anemia |
| Traceability | This method has been | |
| standardized against the Elecsys | ||
| Folate II assay | This method has been standardized | |
| against the Elecsys Folate assay |
. . . . . . .
5
| Reagent Stability | Unopened 2-8°C - up to
expiration
Opened 2-8°C - 8 weeks
On Elecsys 2010 and cobas e411-
2 weeks | Unopened 2-8°C - up to expiration
Opened 2-8°C -12 weeks
On Elecsys 2010 and cobas e411- 2
weeks |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measuring
Range | 1.5 - 20.0 ng/mL | 0.600 - 20.00 ng/mL |
| Precision | Elecsys 2010 and cobas e411 Total
Precision
(range of values)
PreciControl Anemia 2: SD 0.467 ng/mL; CV 6.4% PreciControl Anemia 3: SD 0.986 ng/mL; CV 6.3% Human Samples 10 ng/mL, CV 5.0% | Elecsys 2010 and cobas e411 Total Precision
(range of values)
PreciControl Universal 1: SD 0.82 ng/ml; CV 6.8% PreciControl Universal 2: SD 0.50 ng/ml; CV 7.9% Human Samples 10 ng/mL, CV 7.0% |
| Analytical
Sensitivity | Limit of Blank = ≤0.640 ng/mL
Limit of Detection = ≤1.5 ng/mL
Limit of Quantitation = ≤2.0 ng/mL | Lower Detection Limit = 0.6 ng/mL |
| Analytical
Specificity | The following cross-reactivities
were found:
Aminopterin 2.7%
Folinic acid 2.3%
Amethopterin 2.3% | Same |
| | | |
| Interferences | • The assay is unaffected by icterus
(bilirubin 5 ng/mL and
5
mg/day), no sample should be
taken until at least 8 hours after
the last biotin administration.
• No interference was observed
from rheumatoid factors up to a
concentration of 1000 IU/mL.
• In vitro tests were performed on
18 commonly used
pharmaceuticals and in addition
on human erythropoietin. No
interference with the assay was
found. | • The assay is unaffected by icterus
(bilirubin 5 mg/day), no sample
should be taken until at least 8 hours
after the last biotin administration.
• No interference was observed from
rheumatoid factors up to a concentration
of 1000 IU/mL.
• In vitro tests were performed on 56
commonly used pharmaceuticals and in
addition on human erythropoietin. No
interference with the assay was found. |
| | • It is contraindicated to measure
samples of patients receiving
therapy with certain
pharmaceuticals, e.g.
methotrexate or leucovorin,
because of the cross-reactivity of
folate binding protein with these
compounds. | • Folate assays of samples from patients
receiving therapy with certain
pharmaceuticals, e.g. methotrexate or
leucovorin, are contraindicated because
of the cross-reactivity of folate binding
protein with these compounds. |
| | • In rare cases, interference due to
extremely high titers of | • In rare cases, interference due to
extremely high titers of antibodies to |
| | antibodies to streptavidin and
ruthenium can occur. | streptavidin and ruthenium can occur. |
| Dilution | Sample measuring >20ng/mL can
be manually diluted and a dilution
factor of 2 applied | Sample measuring >20ng/mL can be
manually diluted and a dilution factor of
2 applied |
| Expected Values | American Journal of Clinical
Nutrition
Expected = 4.6 - 34.8 ng/mL
(all ages & male/female) | New England Journal Of Medicine
Expected = 3.1 – 17.5 ng/mL |
・
:
Elecsys Folate III Test System (including RBC Folate Hemolyzing Reagent)
.
:
.
:
6
' :
7
: : : : : :
ﺴﺮ
:
·
.
:
:
| Method
Comparison | A comparison of the Elecsys Folate III assay (Elecsys 2010 Immunoassay
analyzer) and the Elecsys Folate II assay (Elecsys 2010 Immunoassay
analyzer) where N=98
Sample concentrations were between approx. 1.76 and 15.9 ng/mL
Passing/Bablock:
Slope = 1.13
Y intercept = -0.10
tau = 0.833
Linear Regression
Slope = 1.13
Y intercept = -0.06
r=0.962 |
| ---------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
:
:
:
:
. :
11 - 11 - 11
8
| (2) Elecsys RBC Folate Hemolyzing Reagent | ||
|---|---|---|
| Feature | Elecsys RBC Folate | |
| Hemolyzing Reagent | Predicate | |
| Elecsys RBC Folate Hemolyzing | ||
| Reagent | ||
| (K051292) | ||
| Intended Use/Indications for Use | Elecsys RBC Folate | |
| Hemolyzing Reagent is used | ||
| together with the Elecsys Folate | ||
| III assay for the quantitative | ||
| determination of folate in | ||
| erythrocytes (RBC folate) on | ||
| the Elecsys 2010/cobas e 411 | ||
| analyzers. | Elecsys RBC Folate Hemolyzing | |
| Reagent is used together with the | ||
| Elecsys Folate II assay for the | ||
| quantitative determination of | ||
| folate in erythrocytes (RBC | ||
| folate). | ||
| Expected Values | Study in the USA using the | |
| Elecsys Folate III assay the | ||
| cobas e411 Immunoassay | ||
| analyzer, N=262: | ||
| (Values corrected for hematocrit) | ||
| Median - 902 ng/mL | ||
| $2.5^{th}97.5^{th}$ percentile – 499- | ||
| 1504 ng/mL | Study in the USA using the | |
| Elecsys Folate III assay on the | ||
| Elecsys 2010 and cobas e411 | ||
| Immunoassay analyzers, N=121: | ||
| (values corrected for hematocrit) | ||
| Median – 790 ng/mL | ||
| $2.5^{th}97.5^{th}$ percentile – 496-1477 | ||
| ng/mL | ||
| Precision | Total Precision (n=84) | |
| (values not corrected for hematocrit) | ||
| 2010/cobas e411 Analyzer | ||
| 7.0% CV @ 229 ng/mL | ||
| 7.2% CV @ 350 ng/mL | ||
| 7.2% CV @ 481 ng/mL | Total Precision (n=63) | |
| (values corrected for hematocrit) | ||
| 2010/cobas e411 Analyzer | ||
| 6.8% CV @ 478 ng/mL | ||
| 6.6% CV @ 573 ng/mL | ||
| 5.5% CV @ 623 ng/mL | ||
| Measuring | ||
| Range | 46.5 – 572 ng/mL | |
| The lower end of the measuring | ||
| range is derived from the lower | ||
| end of the serum folate test. | ||
| Values are not corrected for | ||
| hematocrit | Without consideration for | |
| hematocrit, up to 620 ng/mL | ||
| (derived from the upper limit of | ||
| the serum folate test) |
·
·
.
9
| Method
Comparison | A comparison of the Elecsys RBC Folate together with the Elecsys
Folate III assay (Elecsys 2010/cobas e411 analyzer; calibrated with
Elecsys Folate III CalSet: y) and the Elecsys RBC Folate with the
Elecsys Folate II assay (Elecsys 2010/cobas e411 analyzer: calibrated
with Elecsys Folate II CalSet II; x) where N=98
(Values were not corrected for Hematocrit)
Sample concentrations were between approx. 123 and 566 ng/mL
Passing/Bablock:
Slope = 1.096
tau = 0.700
Linear Regression
Slope = 1.019
r = 0.921 | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Dilution | Sample measuring >20ng/mL can
be manually diluted and a
dilution factor of 2 applied | Sample measuring >20ng/mL can
be manually diluted and a dilution
factor of 2 applied |
.
| (3) Elecsys Folate III CalSet | ||
|---|---|---|
| Feature | Elecsys Folate III CalSet | Predicate |
| Elecsys Folate II CalSet II | ||
| (K042490) | ||
| Intended Use | Elecsys Folate III CalSet is used | |
| for calibrating the quantitative | ||
| Elecsys Folate III assay on the | ||
| Elecsys and cobas e | ||
| immunoassay analyzers. | Elecsys Folate II CalSet II is used | |
| for calibrating the quantitative | ||
| Elecsys Folate II assay on the | ||
| Elecsys and cobas e immunoassay | ||
| analyzers. | ||
| Levels | Two | Two |
| Matrix | Human serum preserved with | |
| 0.5% Bronidox L and buffered | ||
| with 50mM HEPES | Human serum | |
| Format | Lyophilized | Lyophilized |
| Stability | Unopened: up to the stated | |
| expiration date | ||
| After reconstituting: | ||
| At 2-8C – 3 days | ||
| At -20C – 3 months (freeze only | ||
| once) | ||
| Onboard: use only once | Unopened: up to the stated | |
| expiration date | ||
| After reconstituting: | ||
| At 2-8C – 3 days | ||
| At -20C – 3 months (freeze only | ||
| once) | ||
| Onboard: use only once |
10
| Composition | ||
|---|---|---|
| Buffer: HEPES 50mM | No buffer or preverative in | |
| Preservative: Bronidox L 0.5% | composition |
.
| (4) Elecsys Folate III CalCheck | ||
|---|---|---|
| Feature | Elecsys Folate III CalCheck | Predicate |
| Elecsys Folate II CalCheck II | ||
| (K043320) | ||
| Intended Use | For use in the verification of the | |
| calibration established by the | ||
| Elecsys Folate III reagent on the | ||
| indicated Elecsys and cobas e | ||
| immunoassay analyzers. | For use in the verification of the | |
| calibration established by the | ||
| Elecsys Folate II reagent on the | ||
| indicated Elecsys and cobas e | ||
| immunoassay analyzers. | ||
| Levels | Three | Three |
| Matrix | Human serum preserved with | |
| 0.5% Bronidox L and buffered | ||
| with 50mM HEPES | Human serum | |
| Format | Lyophilized | Lyophilized |
| Stability | Unopened and stored at 2-8C: | |
| up to the stated expiration date | ||
| After reconstituting: 4 hours at | ||
| 20-25C | Unopened and stored at 2-8C: up | |
| to the stated expiration date | ||
| After reconstituting: 4 hours at 20- | ||
| 25C | ||
| Composition | Buffer: HEPES 50mM | |
| Preservative: Bronidox L 0.5% | No buffer or preverative in | |
| composition |
| (5) Elecsys PreciControl Anemia | ||
|---|---|---|
| Feature | Elecsys PreciControl Anemia | Predicate |
| Elecsys PreciControl Anemia | ||
| (K051517) | ||
| Intended Use | Elecsys PreciControl Anemia is | |
| used for quality control of | ||
| Elecsys immunoassays on the | ||
| Elecsys and cobas e | ||
| immunoassay analyzers. | Elecsys PreciControl Anemia is | |
| used for quality control of the | ||
| Elecsys Ferritin, Folate II, and | ||
| Vitamin B12 immunoassays. | ||
| Levels | Three | Three |
| Matrix | Human serum | Human serum |
| Format | Lyophilized | Lyophilized |
11
| Stability | ||
|---|---|---|
| Unopened: up to the stated | ||
| expiration date | Unopened: up to the stated | |
| expiration date | ||
| After reconstituting: | After reconstituting: | |
| At 20-25C: up to 8 hours | At 20-25C: up to 8 hours | |
| On board at 20-25C: up to 5 | ||
| hours | On board at 20-25C: up to 5 hours | |
| At 2-8C: 3 days | At 2-8C: 3 days | |
| At -20C: 1 month (freeze only | ||
| once) | At -20C: 1 month (freeze only once) | |
| After thawing: use only once | After thawing: use only once |
1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -
Elecsys Folate III Test System (including RBC Folate Hemolyzing Reagent)
Page 12 of 12 .
12
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, clutching a staff with a snake wrapped around it, which is a symbol of medicine and health.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 9 2009
Ms. Kathie Goodwin Roche Diagnostics Corp. 9115 Hague Rd. Indianapolis, IA 46250
Re: K082340
Trade/Device Name: Roche Elecsys Folate III, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys Folate III CalSet, Roche Elecsys Folate III CalCheck, Roche Elecsys PreciControl Anemia Regulation Number: 21 CFR 862.1295 Regulation Name: Folic Acid Test System Regulatory Class: Class II Product Code: CGN, JIT, JJY, JJX Dated: June 11, 2009 Received: June 16, 2009
Dear Ms. Goodwin:
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
13
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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).
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.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
14
Indications for Use Form
510(k) Number (if known): K082340
Device Name:
-
(1) Elecsys Folate III
(2) Elecsys RBC Folate Hemolyzing Reagent -
(3) Elecsys Folate III CalSet
(4) Elecsys Folate III CalCheck
(5) Elecsys PreciControl Anemia
Indications for Use:
(1) Elecsys Folate III: Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias. For in vitro diagnostic use.
(2) Elecsys RBC Folate Hemolyzing Reagent: Elecsys RBC Folate Hemolyzing Reagent is used together with the Elecsys Folate III assay for the quantitative determination of folate in erthrocytes (RBC (red blood cell) folate). Binding assay for the in vitro quantitative determination of folate in human serum and plasma. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Measurements obtained by these devices are used in the diagnosis and treatment of anemias.
(3) Elecsys Folate III CalSet: Elecsys Folate III CalSet is used for calibrating the quantitative Elecsys Folate III assay on the Elecsys and cobas e immunoassay analyzers.
(4) Elecsys Folate III CalCheck: Elecsys Folate III CalCheck is used for the verification of the calibration established by the Elecsys Folate III reagent on the indicated Elecsys and cobas e immunoassay analyzers.
(5) Elecsys PreciControl Anemia: Elecsys PreciControl Anemia is used for the quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.
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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082340
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