(56 days)
No
The device description details a standard immunoassay based on electrochemiluminescence and a fixed cut-off formula. There is no mention of AI, ML, or any learning algorithms used in the determination of results.
No
This device is an in vitro diagnostic immunoassay used to aid in the presumptive diagnosis of HSV-2 infection by detecting IgG antibodies, not to treat or cure a disease.
Yes
The Elecsys HSV-2 IgG Immunoassay is described as a "test for the in vitro qualitative determination of IgG class antibodies to HSV-2" and "intended...as an aid in presumptive diagnosis of HSV-2 infection." This directly indicates its role in diagnosing a condition.
No
The device description clearly outlines a two-step sandwich immunoassay utilizing streptavidin microparticles, biotinylated antigens, and electrochemiluminescence detection, which are physical components and processes, 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 Elecsys HSV-2 IgG immunoassay is a test for the in vitro qualitative determination of IgG class antibodies to HSV-2 in human serum and plasma. This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laboratory-based immunoassay that analyzes biological samples (serum and plasma) to detect the presence of antibodies. This is characteristic of an IVD.
- Quality Control: The inclusion of the Elecsys PreciControl HSV, used for quality control of the immunoassay, further supports its classification as an IVD, as quality control is a crucial aspect of laboratory testing.
The information provided clearly indicates that this device is designed to be used outside of the body to analyze human specimens for diagnostic purposes, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
Elecsys HSV-2 IgG Immunoassay:
The Roche Elecsys HSV-2 IgG immunoassay is a test for the in vitro qualitative determination of IgG class antibodies to HSV-2 in human serum and lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended for sexually active individuals and expectant mothers as an aid in presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e immunoassay analyzers.
This test is not FDA cleared for screening blood or plasma donors.
The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients or for use at point of care facilities.
Elecsys PreciControl HSV:
The Elecsys PreciControl HSV is used for quality control of the Elecsys HSV-2 IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
MYF, JJX
Device Description
(1) Elecsys HSV-2 IgG is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated recombinant HSV-2-specific antigen labeled with a ruthenium complex and electrochemiluminescence detection. This assay is a qualitative test based on a cut-off formula dependent on the negative and positive calibrators. Cut-off index (COI) is based on the ratio of assay signal to cut-off signal (also abbreviated s/co). COI values greater than or equal to 1.0 are considered positive for the presence of anti-HSV-2 IgG antibody. Results are determined using a two-point calibration. The test system contains the human serum-based calibrators intended for use with the system.
(2) Elecsys PreciControl HSV contains lyophilized control serum based on human serum. The controls are used for monitoring the accuracy of the Elecsys HSV-2 IgG immunoassay.
Note: The reagent and calibrators are packaged together in the Elecsys HSV-2 IgG assay, while the associated PreciControl is packaged separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Percent Agreement and Sensitivity/Specificity
Expectant Mother Cohort (n=125)
Positive Percent Agreement (95% CI): 97.83% (88.47-99.94%)
Negative Percent Agreement (95% CI): 98.73% (93.15-99.97%)
Sexually Active Cohort (n=469)
Positive Percent Agreement (95% CI): 93.63% (88.60-96.90%)
Negative Percent Agreement (95% CI): 98.72% (96.75-99.65%)
Low Prevalence Cohort (n=200)
Positive Percent Agreement (95% CI): 75.00% (19.41-99.37%)
Negative Percent Agreement (95% CI): 98.47% (95.59-99.68%)
Agreement with CDC Panel: 100%
Analytical Specificity:
311 HSV-2-negative specimens, which were positive for the following cross reactants, were tested with the Elecsys HSV-2 IgG and the comparator assay: Antinuclear antibodies, Varicella zoster virus, Human indefficiency virus, Cytomegalovirus, Neisseria gonorrhea, Toxoplasma gondi, Chlamydia trachomatis, Candida albicans, Epstein Barr virus, Rubella, E. Coli, HSV-1, and Treponema pallidum. 100% agreement was demonstrated between the two assays.
Precision:
Intra-assay:
Low Control: SD 0.005 COI
High Control: CV 1.3%
Serum Samples 0.8 COI: CV 1.2 - 1.6%
Inter-assay:
Low Control: SD 0.010 COI
High Control: CV 3.3%
Serum Samples 0.8 COI: CV 2.8 - 3.6%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement (95% CI): 97.83% (88.47-99.94%) for Expectant Mother Cohort
Negative Percent Agreement (95% CI): 98.73% (93.15-99.97%) for Expectant Mother Cohort
Positive Percent Agreement (95% CI): 93.63% (88.60-96.90%) for Sexually Active Cohort
Negative Percent Agreement (95% CI): 98.72% (96.75-99.65%) for Sexually Active Cohort
Positive Percent Agreement (95% CI): 75.00% (19.41-99.37%) for Low Prevalence Cohort
Negative Percent Agreement (95% CI): 98.47% (95.59-99.68%) for Low Prevalence Cohort
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.
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
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
510(k) Summary
AUG 2 4 2012
| 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 | |
| P.O. Box 50416 | |
| Indianapolis, IN 46250-0416 | |
| Phone: (317) 521-3577 | |
| Fax: (317) 521-2425 | |
| Contact Person: K. Colleen Adams, Regulatory Affairs Principal | |
| Date Prepared: June 27, 2012 | |
| Device Name | |
| Proprietary name: (1) Elecsys HSV-2 IgG Immunoassay | |
| (2) Elecsys PreciControl HSV | |
| Common name: (1) HSV-2 IgG | |
| (2) PreciControl HSV | |
| Classification name: (1) Class 2, 21 CFR 866.3305, Herpes simplex virus serological assays | |
| (2) Class 1, 21 CFR 862.1660, Quality control material (assayed and unassayed) | |
| Product Code: MYF, JJX | |
| Predicate Device: Focus HerpeSelect 1 and 2 Immunoblot IgG (K000238) | |
| Continued on next page |
Continued on next page
ﮯ
·
1
Device Description
(1) Elecsys HSV-2 IgG is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated recombinant HSV-2-specific antigen labeled with a ruthenium complex and electrochemiluminescence detection. This assay is a qualitative test based on a cut-off formula dependent on the negative and positive calibrators. Cut-off index (COI) is based on the ratio of assay signal to cut-off signal (also abbreviated s/co). COI values greater than or equal to 1.0 are considered positive for the presence of anti-HSV-2 IgG antibody. Results are determined using a two-point calibration. The test system contains the human serum-based calibrators intended for use with the system.
(2) Elecsys PreciControl HSV contains lyophilized control serum based on human serum. The controls are used for monitoring the accuracy of the Elecsys HSV-2 IgG immunoassay.
Note: The reagent and calibrators are packaged together in the Elecsys HSV-2 IgG assay, while the associated PreciControl is packaged separately.
| Intended
Use/Indications
| for Use | Elecsys HSV-2 IgG Immunoassay: | |
|---|---|---|
| The Roche Elecsys HSV-2 IgG immunoassay is a test for the in vitro | ||
| qualitative determination of IgG class antibodies to HSV-2 in human serum | ||
| and lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The | ||
| test is intended for sexually active individuals and expectant mothers as an | ||
| aid in presumptive diagnosis of HSV-2 infection. The predictive value of | ||
| positive or negative results depends on the population's prevalence and the | ||
| pretest likelihood of HSV-2. The electrochemiluminescence immunoassay | ||
| "ECLIA" is intended for use on the indicated Elecsys and cobas e | ||
| immunoassay analyzers. |
This test is not FDA cleared for screening blood or plasma donors.
The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients or for use at point of care facilities.
Elecsys PreciControl HSV:
The Elecsys PreciControl HSV is used for quality control of the Elecsys HSV-2 IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.
2
The Elecsys HSV-2 IgG immunoassay test system is substantially Substantial Equivalence equivalent to other devices legally marketed in the United States. (1) Elecsys HSV-2 IgG Immunoassay is equivalent to HerpeSelect 1 and 2 Immunoblot, MRL/Focus Diagnostics (K000238). (2) Elecsys PreciControl HSV is equivalent to the Elecsys PreciControl Anti-CCP (K081338). 1999 - 1999 The following tables compare the Elecsys HSV-2 IgG immunoassay Substantial and PreciControl HSV with their respective predicate devices. Equivalence -Comparison
3
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| Immunoassay Comparison | ||
|---|---|---|
| Feature | Elecsys HSV-2 IgG Immunoassay | |
| (Candidate Device) | Focus HerpeSelect 1&2 | |
| (Predicate Device: K000238) | ||
| General Assay Features | ||
| Intended Use/ | ||
| Indications for Use | The Roche Elecsys HSV-2 IgG | |
| immunoassay is a test for the in vitro | ||
| qualitative determination of IgG class | ||
| antibodies to HSV-2 in human serum | ||
| and lithium-heparin plasma, K2 - | ||
| EDTA plasma, and K3-EDTA plasma. | ||
| The test is intended for sexually active | ||
| individuals and expectant mothers as | ||
| an aid in presumptive diagnosis of | ||
| HSV-2 infection. The predictive value | ||
| of positive or negative results depends | ||
| on the population's prevalence and the | ||
| pretest likelihood of HSV-2. |
The electrochemiluminescence
immunoassay “ECLIA” is intended
for use on the indicated Elecsys and
cobas e immunoassay analyzers.
The test is not FDA cleared for
screening blood or plasma donors.
The performance of this assay has not
been established for use in a pediatric
population, neonates and
immunocompromised patients or for
use at point of care facilities. | Focus Diagnostics' HerpeSelect 1 and
2 Immunoblot IgG test is intended for
qualitatively detecting the presence or
absence of human IgG class antibodies
to HSV-1 and HSV-2 in human sera.
The test is indicated for testing
sexually active adults or expectant
mothers for aiding in the presumptive
diagnosis of HSV-1 and HSV-2
infection. The predictive value of a
positive or negative result depends on
the population's prevalence and the
pretest likelihood of HSV-1 and HSV-
2 infection. The performance of this
assay has not been established for use
in a pediatric population, for neonatal
screening, for testing of
immunocompromised patients, for use
by a point of care facility or for use
with automated equipment. |
| Assay
Protocol | Sandwich assay | Nitrocellulose immunoblot |
| Detection
Protocol | Electrochemiluminescent
Immunoassay | Alkaline phosphatase (qualitative) |
| Applications | 18 minutes | Manual procedure |
| Immunoassay Comparison | | |
| Feature | Elecsys HSV-2 IgG Immunoassay
(Candidate Device) | Focus HerpeSelect 1&2
(Predicate Device: K000238) |
| Instrument
Platform | Elecsys 2010, MODULAR
ANALYTICS E170, cobas e 411,
cobas e 601, and cobas e 602 | Manual procedure |
| Sample
Volume | 20 µL | 20 µL |
| Sample
Type | Human serum and Lithium-heparin,
K2-EDTA, and K3-EDTA plasma | Human serum |
| Reagents | Reagents consist of streptavidin-
coated microparticles, biotinylated
HSV-2 antigen (recombinant, from E.
coli), ruthenylated HSV-2 antigen and
negative and positive calibrators. | Reagents consist of HSV-1 and HSV-
2 differentiation antigen strips,
alkaline phosphatase-conjugated goat
anti-human IgG, bromo-chloro-
indodyl phosphate and nitroblue
tetrazolium substrate and negative and
positive controls. |
| Calibrator | Included with the reagent kit | Not included with this qualitative test |
| Calibration
Interval | Calibration must be performed once
per reagent lot using fresh reagent (i.e.
not more than 24 hours since the
reagent kit was registered on the
analyzer). Renewed calibration is
recommended as follows:
• After 1 month (28 days) when
using the same reagent lot.
• After 7 days (when using the same
reagent kit on the analyzer).
• As required: e.g. quality control
findings outside the specified
limits | Calibrators are not included for this
qualitative assay. Negative and
positive controls are run with every
test. |
| Immunoassay Comparison | | |
| Feature | Elecsys HSV-2 IgG Immunoassay
(Candidate Device) | Focus HerpeSelect 1&2
(Predicate Device: K000238) |
| General Assay Features | | |
| Controls | Elecsys PreciControl HSV | Negative and positive controls are
included with the Focus kit. |
| Traceability /
Standardizati
on | The Elecsys HSV-2 IgG
immunoassay has been standardized
a Roche standard. The units have
been selected arbitrarily. | There is no standardization for this
qualitative assay. |
| Reagent
Stability | Reagents, ready to use:
2-8°C – Up to the stated expiration
date
After opening at 2-8°C – 8 weeks
On the analyzers – 21 days
Calibrators (lyophilized):
Unopened at 2-8°C – Up to stated
expiration date
After reconstitution at 2-8°C – 14
days
On the Elecsys 2010 and cobas e 411
20-25°C – Up to 5 hours
On the MODULAR ANALYTICS
E170, cobas e 601, and cobas e 602
– Use only once | Kits and reagents are stable through
the end of the month indicated on their
expiration dates when stored at 2-8°C. |
| Cutoffs | The analyzer automatically calculates
the cutoff based on the measurement
of Cal 1 and Cal 2. The result of a
sample is given either as reactive or
non-reactive as well as in the form of
a cutoff index. | Positive or negative results are
generated by this qualitative assay by
comparing bands on the nitrocellulose
to a cut-off/control strip. |
| Immunoassay Comparison | | |
| Feature | Elecsys HSV-2 IgG Immunoassay
(Candidate Device) | Focus HerpeSelect 1&2
(Predicate Device: K000238) |
| | General assay features | |
| Cutoffs
(continued) | For the Elecsys HSV-2 IgG
immunoassay, the interpretation of the
results is: | |
| | Non-reactive 0.8 COI:
CV 1.2 - 1.6%
Inter-assay:
Low Control: SD 0.010 COI
High Control: CV 3.3%
Serum Samples 0.8 COI:
CV 2.8 - 3.6% | Inter Laboratory Reproducibility: An
internal investigator and 2 external
laboratories assessed the device's
reproducibility. Seven samples were
run in triplicate on 3 different days.
Using the Focus Elisa Index (negative
if less than 0.90, equivocal if between
0.90 and 1.10, and positive if greater
than 1.10) the manufacturer was able
to demonstrate 100% agreement with
intra-assay, inter-assay, inter-lot and
inter-lab precision testing. |
Comparison of Assays-Similarities and Differences, continued
8
・
| Immunoassay Comparison | ||
|---|---|---|
| Feature | Elecsys HSV-2 IgG Immunoassay | |
| (Candidate Device) | Focus HerpeSelect 1&2 | |
| (Predicate Device: K000238) | ||
| Labeled Performance Characteristics | ||
| Analytical | ||
| Specificity | 311 HSV-2-negative specimens, | |
| which were positive for the following | ||
| cross reactants, were tested with the | ||
| Elecsys HSV-2 IgG and the | ||
| comparator assay: Antinuclear | ||
| antibodies, Varicella zoster virus, | ||
| Human indefficiency virus, | ||
| Cytomegalovirus, Neisseria | ||
| gonorrhea, Toxoplasma gondi, | ||
| Chlamydia trachomatis, Candida | ||
| albicans, Epstein Barr virus, Rubella, | ||
| E. Coli, HSV-1, and Treponema | ||
| pallidum. 100% agreement was | ||
| demonstrated between the two assays. | The sponsor tested 32 HSV negative | |
| samples which were positive for | ||
| Cytomegalovirus, Epstein Barr virus, | ||
| Virus Capsid antigen, Human | ||
| herpesvirus6 or Varicella zoster virus. | ||
| Eight of the samples were found to be | ||
| positive with the Focus Immunoblot, | ||
| while the 24 remaining samples were | ||
| negative. |
Comparison of Assays-Similarities and Differences, continued
9
·
| Comparison of Assays-Similarities and Differences, continued | ||
|---|---|---|
| Immunoassay Comparison | ||
| Feature | Elecsys HSV-2 IgG Immunoassay | |
| (Candidate Device) | Focus HerpeSelect 1&2 | |
| (Predicate Device: K000238) | ||
| Labeled Performance Characteristics | ||
| Limitations | A negative test result does not | |
| completely rule out the possibility of | ||
| an infection with HSV-2 as | ||
| individuals may not exhibit any | ||
| detectable IgG antibodies at the early | ||
| stage of acute infection. |
False negative results may occur when
the HSV virus is glycoprotein G (gG)
deficient (0.2 % HSV isolates were gG
deficient).
The detection of HSV-2-specific IgG
antibodies in a single sample indicates
a previous exposure to HSV-2 but
does not give any information of the
time point of an exposure.
Elecsys HSV-2 IgG results should be
used in conjunction with the patient's
medical history and clinical
symptoms.
The results in HIV patients, in patients
undergoing immunosuppressive
therapy, or in patients with other
disorders leading to immune
suppression, should be interpreted
with caution.
Specimens from neonates, cord blood,
pretransplant patients or body fluids
other than serum and plasma, such as
urine, saliva, or amniotic fluid have
not been tested. | The performance of this assay has
not been established for the general
population. The performance of this assay has
not been established for ruling out
diseases with similar symptoms,
e.g., Candida albicans, Bacteriodes
species, G. vaginalis, Mobiluncus
species. Instead, also use culture or
other appropriate methods. The performance of this assay has
not been established for matrices
other than serum, or visual result
determination(s), or monitoring
HSV therapy. All results from this
and other serologies must be
correlated with clinical history,
epidemiological data, and other
data available to the attending
physician in evaluating the patient. The prevalence of infection will
affect the assay's predictive value. As with other serological tests,
negative results do not rule out the
diagnosis of herpes simplex
disease. The time required to
seroconvert following the primary
infection varies with the
individual; the specimen may have
been drawn prior to the appearance
of detectable antibodies. False negative results may occur
when the infecting virus is gG
deficient, or because it is unknown
if the assay's antigen was
glycosylated the same as
mammalian cells. |
Comparison of Assays—Similarities and Differences, continued
Continued on next page
.
10
| Immunoassay Comparison | ||
|---|---|---|
| Feature | Elecsys HSV-2 IgG Immunoassay | |
| (Candidate Device) | Focus HerpeSelect 1&2 | |
| (Predicate Device: K000238) | ||
| Labeled Performance Characteristics | ||
| Limitations, | ||
| continued | The assay is unaffected by icterus | |
| (bilirubin 5 mg/day) until at | ||
| least 8 hours following the last biotin | ||
| administration. | ||
| No interference was observed from | ||
| rheumatoid factors up to a | ||
| concentration of 1500 IU/mL. | ||
| In vitro tests were performed on 18 | ||
| commonly used pharmaceuticals and | ||
| in addition on Famciclovir, Acyclovir | ||
| and Valacyclovir. No interference | ||
| with the assay was found. | ||
| Assay performance for sodium citrate | ||
| plasma has not been evaluated. |
Comparison of Assays-Similarities and Differences, continued
11
| Comparison of Assays-Similarities and Differences, continued | ||
|---|---|---|
| Immunoassay Comparison | ||
| Feature | Elecsys HSV-2 IgG Immunoassay | |
| (Candidate Device) | Focus HerpeSelect 1&2 | |
| (Predicate Device: K000238) | ||
| Labeled Performance Characteristics | ||
| Limitations, | ||
| continued | In rare cases, interference due to | |
| extremely high titers of antibodies to | ||
| streptavidin or ruthenium can occur. | ||
| These effects are minimized by | ||
| suitable test design. |
Cross-reactivity for HPV and various
types of bacterial vaginosis-causing
agents (e.g., Mobiluncus spec,
Gardnerella vaginalis, and
Bacteroides spec) were not evaluated
in the performance analysis of this
assay. The influence of the serological
response against any of these agents
on the results of the Elecsys HSV-
2 IgG immunoassay is unknown.
Sample stability studies were
performed using serum only.
Results should always be assessed in
conjunction with the patient's medical
history, clinical examination and other
findings. | |
:
Comparison of Assays—Similarities and Differences, continued
12
| Immunoassay Comparison, continued | ||
|---|---|---|
| Feature | Elecsys HSV-2 IgG Immunoassay | |
| (Candidate Device) | Focus HerpeSelect 1&2 | |
| (Predicate Device: K000238) | ||
| Labeled Performance Characteristics | ||
| Percent | ||
| Agreement | ||
| and | ||
| Sensitivity/ | ||
| Specificity | Expectant Mother Cohort (n=125) | Relative Sensitivities to Western |
| Blot | ||
| Positive Percent Agreement (95% CI): | Pregnant Cohort: 100% | |
| 97.83% (88.47-99.94%) | Sexually Active Adults: 99.3% | |
| Negative Percent Agreement (95% CI): | Low Prevalence Population: 82.4% | |
| 98.73% (93.15-99.97%) | ||
| Sexually Active Cohort (n=469) | Relative Specificity to Western Blot | |
| Positive Percent Agreement (95% CI): | Pregnant Cohort: 93.1% | |
| 93.63% (88.60-96.90%) | Sexually Active Adults: 95.1% | |
| Negative Percent Agreement (95% CI): | ||
| 98.72% (96.75-99.65%) | Low Prevalence Population: 100% | |
| Low Prevalence Cohort (n=200) | ||
| Positive Percent Agreement (95% CI): | ||
| 75.00% (19.41-99.37%) | ||
| Negative Percent Agreement (95% CI): | ||
| 98.47% (95.59-99.68%) | ||
| Agreement | ||
| with CDC | ||
| Panel | 100% | 100% |
Comparison of Assays—Similarities and Differences, continued
13
| Comparison of Controls – Similarities and Differences | ||
|---|---|---|
| Characteristic | Elecsys PreciControl HSV | |
| (Candidate Device) | Predicate Device: | |
| Elecsys PreciControl Anti-CCP | ||
| (K081338) | ||
| Intended Use | The Elecsys PreciControl HSV is used | |
| for quality control of the Elecsys | ||
| HSV-2 IgG immunoassay on the | ||
| Elecsys and cobas e immunoassay | ||
| analyzers. | Elecsys PreciControl Anti-CCP is | |
| used for quality control of the | ||
| Elecsys Anti-CCP immunoassay on | ||
| the Elecsys and cobas e | ||
| immunoassay analyzers. | ||
| Levels | Two | Two |
| Format | Lyophilized | Lyophilized |
| Matrix | Human serum negative for HSV-2 IgG | |
| antibodies | Human serum | |
| Analyte | PreciControl 1: ~ 0.30 COI | PreciControl 1: ~20 U/mL |
| Concentration | PreciControl 2: ~ 8.00 COI | PreciControl 2: ~100 U/mL |
| Stability | Unopened: | |
| ● Store at 2-8°C up to the stated | ||
| expiration date | ||
| Reconstituted: | ||
| ● 2 - 8°C: 21 days | ||
| ● On the Elecsys 2010 and cobas e | ||
| 411 analyzers at 20-25°C: Up to | ||
| 5 hours | ||
| ● On the MODULAR | ||
| ANALYTICS E170, cobas e 601, | ||
| and cobas e 602 analyzers: Up to | ||
| 2 hours | Unopened: | |
| ● Store at 2-8°C up to the | ||
| stated expiration date | ||
| Reconstituted: | ||
| ● -20°C: 1 month (freeze only | ||
| once) | ||
| ● On the analyzers at 20- | ||
| 25°C: Up to 5 hours | ||
| ● After thawing: Use only | ||
| once | ||
| Handling | Dissolve carefully the contents of one | |
| bottle by adding exactly 3.0 mL of | ||
| distilled or deionized water and allow | ||
| to stand closed for 15 minutes to | ||
| reconstitute. Mix carefully, avoiding | ||
| the formation of foam. Use a pipette to | ||
| transfer the reconstituted control of 1 | ||
| bottle into empty labeled Elecsys | ||
| snap-cap bottles supplied. | Dissolve carefully the contents of | |
| one bottle by adding exactly 2.0 mL | ||
| of distilled water and allow to stand | ||
| closed for 15 minutes to | ||
| reconstitute. Mix carefully, | ||
| avoiding the formation of foam. | ||
| Transfer aliquots of the freshly | ||
| reconstituted controls into | ||
| appropriate tubes for storage. Store | ||
| the aliquots immediately at -20°C. |
Comparison of Controls - Similarities and Differences
14
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/14/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" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Roche Diagnostics c/o Ms. K. Colleen Adams Regulatory Affairs Principal 9115 Hague Road, P.O. Box 50416 Indianapolis, IN 46250-0416
AUG 2 4 2012
Re: K121895
Trade/Device Name: Elecsys HSV-2 IgG Immunoassay and PreciControl HSV Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: Class II Product Code: MYF, JJX Dated: June 27, 2012 Received: June 29, 2012
Dear Ms. Adams:
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 class II (Special Controls), 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). 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
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Page 2 - Ms. Colleen Adams
predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
Elecsvs HSV-2 IgG Immunoassay and PreciControl HSV Device Name:
Indications for Use:
Elecsys HSV-2 IgG Immunoassay
The Roche Elecsvs HSV-2 IgG immunoassay is a test for the in vitro qualitative determination of IgG class antibodies to HSV-2 in human serum and lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended for sexually active individuals and expectant mothers as an aid in presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e immunoassay analyzers.
This test is not FDA cleared for screening blood or plasma donors.
The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients or for use at point of care facilities.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
fayann
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121895
Page 1 of 2
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Indications for Use
Elecsys PreciControl HSV
The Elecsys PreciControl HSV is used for quality control of the Elecsys HSV-2 IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
Tamara Tedder
Division Sign-Off
Division Sign-Off
- Office of In Vitro Diagnostic Device Eyaluation and Safety
510(k) K121895