(146 days)
Not Found
No
The device description details a standard immunoassay technology (ECLIA) with a fixed cut-off formula based on calibrators. There is no mention of adaptive algorithms, learning from data, or any characteristics typically associated with AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is an in vitro diagnostic immunoassay that aids in the presumptive diagnosis of HSV-1 infection by detecting antibodies, not a therapeutic device meant for treatment.
Yes
The product description states, "The test is intended for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 infection." This clearly indicates its role in diagnosing a medical condition.
No
The device description clearly outlines a two-step sandwich immunoassay involving physical components like streptavidin microparticles, biotinylated recombinant antigen, and electrochemiluminescence detection, which are hardware-based elements. It also mentions the use of calibrators and control serum, which are reagents, not software. The device is intended for use on Elecsys and cobas e immunoassay analyzers, which are also hardware systems.
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 test is for the "in vitro qualitative determination of IgG class antibodies to HSV-1 in human serum and lithium-heparin plasma, K2—EDTA plasma, and K3—EDTA plasma." The term "in vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The test analyzes human biological samples (serum and plasma), which is typical for IVDs used for diagnostic purposes.
- Purpose: The test is intended as an "aid in the presumptive diagnosis of HSV-1 infection," which is a diagnostic purpose.
- Device Description: The description details a laboratory-based immunoassay system that analyzes samples using specific reagents and instrumentation (Elecsys and cobas e immunoassay analyzers). This is consistent with the nature of IVD devices.
- Quality Control: The mention of "PreciControl HSV" for quality control further indicates a system designed for laboratory diagnostic testing.
Therefore, based on the provided information, the Roche Elecsys HSV-1 IgG immunoassay clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Roche Elecsys HSV-1 IgG immunoassay is a test for the in vitro qualitative determination of IgG class antibodies to HSV-1 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 the presumptive diagnosis of HSV-1 infection. The predictive value of positive and negative results depends on the population's prevalence and the pretest likelihood of HSV-1. The electrochemiluminescence immunoassay "ECLIA" is intended for use on 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, immunocompromised patients, or for use at point of care facilities.
PreciControl HSV: PreciControl HSV is used for quality control of the Elecsys HSV-1 IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
MXJ, JJX
Device Description
(1) The Elecsys HSV-1 IgG immunoassay is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated recombinant HSV-1-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-1 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) PreciControl HSV contains lyophilized control serum based on human serum. The controls are used for monitoring the accuracy of the Elecsys HSV-1 IgG immunoassay. Note: The reagents and calibrator are packaged together in the Elecsys HSV-1 IgG immunoassay, 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
Not Found
Indicated Patient Age Range
The performance of this assay has not been established for use in a pediatric population, neonates.
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:
Intra-assay: Low Control: SD 0.003 COI, High Control: CV 1.0%, Serum Samples 0.8 COI: CV 1.0 – 1.3%.
Inter-assay: Low Control: SD 0.006 COI, High Control: CV 2.5%, Serum Samples 0.8 COI: CV 2.6 – 2.9%.
Analytical Specificity:
129 HSV-negative specimens, which were positive for the following cross reactants, were tested with the Elecsys HSV-1 IgG immunoassay and the comparator assay: Antinuclear antibodies, Varicella zoster virus, Human deficiency virus, Cytomegalovirus, Neisseria gonorrhea, Toxoplasma gondi, Chlamydia trachomatis, Candida albicans, Epstein Barr virus, Rubella, E. Coli, Treponema pallidum, and HSV-2. 100% agreement was demonstrated between the two assays.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Expectant Mother Cohort (n=125)
Positive Percent Agreement (95% CI): 91.0% (82.4-96.3%)
Negative Percent Agreement (95% CI): 95.7% (85.5-99.5%)
Sexually Active Cohort (n=600)
Positive Percent Agreement (95% CI): 94.2% (91.3-96.4%)
Negative Percent Agreement (95% CI): 90.3% (85.9-93.8%)
Low Prevalence Cohort (n=200)
Positive Percent Agreement (95% CI): 94.9% (87.4-98.6%)
Negative Percent Agreement (95% CI): 96.7% (91.8-99.1%)
Agreement with CDC Panel: 100%
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.
Focus HerpeSelect 1 and 2 Immunoblot IgG (K000238)
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
§ 866.3305 Herpes simplex virus serological assays.
(a)
Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.(b)
Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
0
120625
510(k) Summary
JUL 2 5 2012
1
| 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 | |
| Phone: (317) 521-2458 | |
| Fax: (317) 521-2324 | |
| Email: colleen.adams@roche.com | |
| Contact Person: K. Colleen Adams, Regulatory Affairs Principal | |
| Date Prepared: February 29, 2012 | |
| Device Name | |
| Proprietary name: (1) Elecsys HSV-1 IgG Immunoassay | |
| (2) PreciControl HSV | |
| Common name: (1) HSV-1 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: (1) MXJ | |
| (2) JJX | |
| Predicate Device: Focus HerpeSelect 1 and 2 Immunoblot IgG (K000238) |
Continued on next page
1
(1) The Elecsys HSV-1 IgG immunoassay is a two-step sandwich Device immunoassay with streptavidin microparticles, biotinylated recombinant Description HSV-1-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-1 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) PreciControl HSV contains lyophilized control serum based on human serum. The controls are used for monitoring the accuracy of the Elecsys HSV-1 IgG immunoassay. Note: The reagents and calibrator are packaged together in the Elecsys HSV-1 IgG immunoassay, while the associated PreciControl is packaged separately. Elecsys HSV-1 IgG Immunoassay: Intended The Roche Elecsys HSV-1 IgG immunoassay is a test for the in vitro Use/Indications for Use qualitative determination of IgG class antibodies to HSV-1 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 the presumptive diagnosis of HSV-1 infection. The predictive value of positive and negative results depends on the population's prevalence and the pretest likelihood of HSV-1. The electrochemiluminescence immunoassay "ECLIA" is intended for use on 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, immunocompromised patients, or for use at point of care facilities. Continued on next page
2
2
· ____________________________________________________________________________________________________________________________________________________________________________
:
| Intended
Use/Indications
for Use,
continued | PreciControl HSV:
PreciControl HSV is used for quality control of the Elecsys HSV-1 IgG
immunoassay on the Elecsys and cobas e immunoassay analyzers. |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence | The Elecsys HSV-1 IgG test system is substantially equivalent to other
devices legally marketed in the United States. |
| | (1) Elecsys HSV-1 IgG immunoassay is equivalent to HerpeSelect 1
and 2 Immunoblot, MRL/Focus Diagnostics (K000238). |
| | (2) PreciControl HSV is equivalent to the Elecsys PreciControl
Anti-CCP (K081338). |
| Substantial
Equivalence -
Comparison | The following tables compare the Elecsys HSV-1 IgG immunoassay
and PreciControl HSV with their respective predicate devices. |
| | Continued on next page |
'
:
・ 3
3
| Immunoassay Comparison | ||
|---|---|---|
| Feature | Elecsys HSV-1 IgG Immunoassay | |
| (Candidate Device) | Focus HerpeSelect 1&2 | |
| (Predicate Device: K000238) | ||
| General Assay Features | ||
| Intended Use/ | ||
| Indications for Use | The Roche Elecsys HSV-1 IgG | |
| immunoassay is a test for the in vitro | ||
| qualitative determination of IgG class | ||
| antibodies to HSV-1 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 the | ||
| presumptive diagnosis of HSV-1 | ||
| infection. The predictive value of | ||
| positive and negative results depends | ||
| on the population's prevalence and the | ||
| pretest likelihood of HSV-1. |
The electrochemiluminescence
immunoassay “ECLIA” is intended
for use on 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,
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-1 IgG Immunoassay
(Candidate Device) | Focus HerpeSelect 1&2
(Predicate Device: K000238) |
| General Assay Features | | |
| 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-1 antigen (recombinant, from E. coli ), ruthenylated HSV-1 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 reagents
kept on board the analyzer).
• As required: e.g. quality control
findings outside the specified | Calibrators are not included for this
qualitative assay. Negative and
positive controls are run with every
test. |
Comparison of Assays—Similarities and Differences
4
Comparison of Assays—Similarities and Differences, continued
Continued on next page
.
.
5
| Immunoassay Comparison | ||
|---|---|---|
| Feature | Elecsys HSV-1 IgG Immunoassay | |
| (Candidate Device) | Focus HerpeSelect 1&2 | |
| (Predicate Device: K000238) | ||
| General Assay Features | ||
| Controls | PreciControl HSV | Negative and positive controls are |
| included with the Focus kit. | ||
| Traceability / | ||
| Standardization | The Elecsys HSV-1 IgG | |
| immunoassay has been standardized | ||
| against a Roche standard. The units | ||
| have been selected arbitrarily. | There is no standardization for this | |
| qualitative assay. | ||
| Reagent | ||
| Stability | Reagents, ready to use: | |
| Unopened at 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. |
Comparison of Assays—Similarities and Differences, continued
6
.
.
510(k) Summary, Continued
| Comparison of Assays—Similarities and Differences, continued | ||
|---|---|---|
| Immunoassay Comparison | ||
| Feature | Elecsys HSV-1 IgG Immunoassay | |
| (Candidate Device) | Focus HerpeSelect 1&2 | |
| (Predicate Device: K000238) | ||
| General assay features | ||
| Cutoffs | ||
| (continued) | For the Elecsys HSV-1 IgG | |
| immunoassay, the interpretation of the | ||
| results is: | ||
| Non-reactive 0.8 COI: | ||
| CV 1.0 – 1.3% |
Inter-assay:
Low Control: SD 0.006 COI
High Control: CV 2.5%
Serum Samples 0.8 COI:
CV 2.6 – 2.9% | 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. |
| Analytical
Specificity | 129 HSV-negative specimens, which were positive for the following cross reactants, were tested with the Elecsys HSV-1 IgG immunoassay and the comparator assay: Antinuclear antibodies, Varicella zoster virus, Human deficiency virus, Cytomegalovirus, Neisseria gonorrhea, Toxoplasma gondi, Chlamydia trachomatis, Candida albicans, Epstein Barr virus, Rubella, E. Coli, Treponema pallidum, and HSV-2. 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
Immunoassay Comparison | | |
| Elecsys HSV-1 IgG Immunoassay | | Focus HerpeSelect 1&2 |
| Feature | (Candidate Device) | (Predicate Device: K000238) |
| | Labeled Performance Characteristics
| |
| Limitations | A negative test result does not
completely rule out the possibility of
an infection with HSV-1 as
individuals may not exhibit any
detectable IgG antibodies at the early
stage of acute infection. | The performance of this assay has not
been established for the general
population. |
| | False negative results may occur when
the HSV virus is glycoprotein G (gG)
deficient (0.2 % HSV isolates were gG
deficient). | 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 detection of HSV-1-specific IgG
antibodies in a single sample indicates
a previous exposure to HSV-1 but
does not give any information of the
time point of an exposure. | 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. |
| | Results from the Elecsys HSV-1 IgG
immunoassay should be used in
conjunction with the patient's medical
history and clinical symptoms. | The prevalence of infection will affect
the assay's predictive value. |
| | 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. | As with other serological tests,
negative results do not rule out the
diagnosis of herpes simplex disease. |
| | 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 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. |
| Immunoassay Comparison | | |
| Feature | Elecsys HSV-1 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. | A single positive result only indicates
previous immunologic exposure; level of
antibody response or class of antibody
response may not be used to determine
active infection or disease state. |
| | No interference was observed from
rheumatoid factors up to a concentration
of 1500 IU/mL. | The magnitude of the index value above
the Cut-off does not indicate the total
amount of antibody present. |
| | In vitro tests were performed on 18
commonly used pharmaceuticals and in
addition on Famciclovir, Aciclovir and
Valaciclovir. No interference with the
assay was found. | Serology cannot distinguish genital from
oral infections. When appropriate, culture
is recommended to identify the infection
site. However, false negative HSV
cultures are common, especially in
patients with recurrent infection or with
healing lesions. |
| | Assay performance for sodium citrate
plasma has not been evaluated. | |
| Comparison of Assays-Similarities and Differences, continued
Immunoassay Comparison | | |
| Feature | Elecsys HSV-1 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-1 IgG immunoassay
is unknown. | |
| | Sample stability studies were performed
using serum only.
For diagnostic purposes, the 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
in the
Continued on next page
. . . . . . . . . . . . .
8
8
510(k) Summary, Continued
mparison of Assays-ﺮ ﺍ Similarities and Differences, continued
6 - : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
.
9
Comparison of Assays-Similarities and Differences, continued
・
10
rison of Assays-Similarities and Differences, continued ﻟﺴﻴﺎﺳﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ --- -- -- --
11
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
510(k) Summary, Continued
| Comparison of Assays—Similarities and Differences, continued | ||
|---|---|---|
| Immunoassay Comparison | ||
| Feature | Elecsys HSV-1 IgG Immunoassay | |
| (Candidate Device) | Focus HerpeSelect 1&2 | |
| (Predicate Device: K000238) | ||
| Labeled Performance Characteristics | ||
| Percent | ||
| Agreement or | ||
| Sensitivity/ | ||
| Specificity | Expectant Mother Cohort (n=125) | |
| Positive Percent Agreement (95% CI): | ||
| 91.0% (82.4-96.3%) | ||
| Negative Percent Agreement (95% CI): | ||
| 95.7% (85.5-99.5%) | Relative Sensitivities to Western Blot | |
| Pregnant Cohort: 100% | ||
| Sexually Active Adults: 99.3% | ||
| Low Prevalence Population: 82.4% | ||
| Sexually Active Cohort (n=600) | ||
| Positive Percent Agreement (95% CI): | ||
| 94.2% (91.3-96.4%) | ||
| Negative Percent Agreement (95% CI): | ||
| 90.3% (85.9-93.8%) | Relative Specificity to Western Blot | |
| Pregnant Cohort: 93.1% | ||
| Sexually Active Adults: 95.1% | ||
| Low Prevalence Population: 100% | ||
| Low Prevalence Cohort (n=200) | ||
| Positive Percent Agreement (95% CI): | ||
| 94.9% (87.4-98.6%) | ||
| Negative Percent Agreement (95% CI): | ||
| 96.7% (91.8-99.1%) | ||
| Agreement | ||
| with CDC | ||
| Panel | 100% | 100% |
Similarities and Diffe - - - -..............................................................................................................................................................................
Continued on next page
.
12
.
510(k) Summary, Continued
| Characteristic | PreciControl HSV
(Candidate Device) | Predicate Device:
Elecsys PreciControl Anti-CCP
(K081338) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | PreciControl HSV is used for quality
control of the Elecsys HSV-1 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-1 IgG
antibodies | Human serum |
| Analyte
Concentration | PreciControl 1: ~0.30 COI
PreciControl 2: ~4.00 COI | PreciControl 1: ~20 U/mL
PreciControl 2: ~100 U/mL |
| Stability | Unopened:
• Store at 2-8°C up to the stated
expiration date
Reconstituted:
• 2 - 8°C: 14 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
13
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/13/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 symbol resembling an eagle or bird with three stylized human profiles forming its body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
JUL 25 2012
Roche Diagnostics c/o Ms. K. Colleen Adams, MTSC Regulatory Affairs Principal 9115 Hague Road, P.O. Box 50416 Indianapolis, IN 46250-0146
Re: K120625
Trade/Device Name: Elecsys HSV-1 IgG Immunoassay and PreciControl HSV Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: Class II Product Code: MXJ, JJX Dated: June 25, 2012 Received: June 26, 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
14
Page 2 – Ms. Colleen Adams
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 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,
Uke Self for
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
15
Indications for Use
Elecsys HSV-1 IgG Immunoassay Device Name:
Indications For Use: The Roche Elecsys HSV-1 IgG immunoassay is a test for the in vitro qualitative determination of IgG class antibodies to HSV-1 in human serum and lithiumheparin plasma, K2 EDTA plasma, and K3 EDTA plasma. The test is intended for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 infection. The predictive value of positive and negative results depends on the population's prevalence and the pretest likelihood of HSV-1.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on 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, 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In. Vitro Diagnostic-Devices (OLVD)
I ama a let de Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
510(k) K/20625
16
Indications for Use
PreciControl HSV Device Name:
Indications For Use: PreciControl HSV is used for quality control of the Elecsys HSV-1 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)
ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ 2 Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
k 12 0625 510(k).