(181 days)
P790019/S011
Not Found
No
The description focuses on a standard immunoassay technology (ECLIA) and does not mention any AI/ML components in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic immunoassay used to detect antibodies for diagnosis, not to treat a condition.
Yes
The device is described as an aid in the "laboratory diagnosis" of hepatitis A virus infection.
No
The device description clearly outlines a physical immunoassay kit with reagents (antibodies, microparticles) and is intended for use on specific hardware analyzers (Elecsys and cobas e). This is a hardware-based in vitro diagnostic device, not software only.
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 assay is used for the "in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma". The term "in vitro" is a key indicator of an IVD.
- Sample Type: The assay analyzes human serum and plasma, which are biological specimens taken from the body.
- Purpose: The assay is intended as an "aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection". This diagnostic purpose, performed outside of the body, is characteristic of an IVD.
- Device Description: The description details a laboratory-based immunoassay technology ("electrochemiluminescence immunoassay 'ECLIA'") performed on specific analyzers ("Elecsys and cobas e immunoassay analyzers").
- Quality Control: The mention of "Elecsys PreciControl Anti-HAV IgM" for quality control further reinforces its use in a laboratory setting for diagnostic testing.
N/A
Intended Use / Indications for Use
The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection.
Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis A infection.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Elecsys PreciControl Anti-HAV IgM is used for quality control of the Elecsys Anti-HAV IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.
Product codes
LOL, JJX
Device Description
The Elecsys Anti-HAV IgM immunoassay utilizes a u-capture test concept based on a monoclonal h-IgM directed biotinylated antibody, cell culture derived Hepatitis A Virus and a ruthenylated monoclonal antibody directed to HAV. Capture of formed immune complexes from the reaction mixture is based on biotin binding to streptavidin-coated magnetic microparticles which are collected on a measuring cell electrode. Signal generation is triggered by the application of a voltage to the electrode (electrochemiluminescence technology). The level of signal count detected by the system increases as the concentration of the IgM antibody target present in a patient sample increases.
The Elecsys PreciControl Anti-HAV IgM contains control serum based on human serum in the negative and positive concentration range. The controls are used for monitoring the accuracy of the Elecsys Anti-HAV IgM 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
Description of the test set: A multi-center study was conducted in the U.S. to characterize the performance of the Elecsys Anti-HAV IgM immunoassay. All subjects were tested with the Elecsys Anti-HAV IgM assay on the Elecsys 2010 analyzer and with an FDA-cleared reference method in strict accordance with the manufacturer's package insert instructions.
Sample size: A total of 1087 samples were obtained from multiple specimen sources.
Data source: Samples representing subjects for whom routine hepatitis A testing had been ordered, hospitalized patients, subjects at increased risk for hepatitis, subjects with signs and symptoms of hepatitis, subjects characterized with acute hepatitis A, and subjects below the age of 21 years (pediatric/adolescents).
Annotation protocol: Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: Comparative Testing.
Sample size: 1087.
Key results: For the overall clinical population, the positive percent agreement was 97.5% (118/121) with a 95% confidence interval of 92.9% - 99.5%. The negative percent agreement was 99.3% (959/966) with a 95% confidence interval of 98.5% - 99.7%. Discrepant samples were further tested with a second FDA cleared anti-HAV IgM assay, showing agreement with Elecsys in 7 out of 10 discrepant samples.
Study type: Analytical Sensitivity.
Sample size: Three commercially available HAV seroconversion panels.
Key results: The Elecsys Anti-HAV IgM immunoassay showed comparable or earlier reactive results for the tested seroconversion panels when compared to the FDA approved comparator assay and vendor assay (both based on Abbott HAVAB-M). For Panel HAV-01, Elecsys detected reactivity at Day 0, while comparators detected at Day 0. For PHT 902, Elecsys detected reactivity at Day 16, consistent with the vendor assay (comparator not tested). For RP013, Elecsys detected reactivity at Day 9, earlier than both comparators (Day 51).
Study type: Expected Values (Prevalence).
Sample size: 602 apparently healthy individuals (300 subjects from New Mexico, 302 from Indiana).
Key results:
Low prevalence region (Indiana): The prevalence rate for reactive anti-HAV IgM antibody was 0.00%.
High prevalence region (New Mexico): The prevalence rate for reactive anti-HAV IgM antibody was 0.33%.
Study type: Precision/Reproducibility.
Sample size: Three human serum pools and two PreciControl Anti-HAV IgM materials.
Key results:
Precision on Elecsys 2010 analyzer (single lot of reagent, 2 replicates/day for 20 days):
HSP1 (high negative): Mean COI 0.884, Repeatability SD 0.018 (CV 2.1%), Intermediate precision SD 0.035 (CV 4.0%).
HSP2 (low positive): Mean COI 1.14, Repeatability SD 0.030 (CV 2.6%), Intermediate precision SD 0.051 (CV 4.5%).
HSP3 (moderately positive): Mean COI 2.23, Repeatability SD 0.060 (CV 2.7%), Intermediate precision SD 0.094 (CV 4.2%).
PC A-HAVIGM1: Mean COI 0.230, Repeatability SD 0.004 (CV 1.5%), Intermediate precision SD 0.009 (CV 4.1%).
PC A-HAVIGM2: Mean COI 2.04, Repeatability SD 0.050 (CV 2.5%), Intermediate precision SD 0.098 (CV 4.8%).
Precision on MODULAR ANALYTICS E170 analyzers:
HSP1: Mean COI 0.929, Repeatability SD 0.018 (CV 1.9%), Intermediate precision SD 0.040 (CV 4.4%).
HSP2: Mean COI 1.22, Repeatability SD 0.024 (CV 2.0%), Intermediate precision SD 0.060 (CV 4.9%).
HSP3: Mean COI 2.36, Repeatability SD 0.052 (CV 2.2%), Intermediate precision SD 0.110 (CV 4.7%).
PC A-HAVIGM1: Mean COI 0.217, Repeatability SD 0.005 (CV 2.3%), Intermediate precision SD 0.010 (CV 4.5%).
PC A-HAVIGM2: Mean COI 2.13, Repeatability SD 0.043 (CV 2.0%), Intermediate precision SD 0.110 (CV 5.1%).
Reproducibility on Elecsys 2010 analyzer (three external sites, 3 replicates/day for 5 days):
HSP1: Mean COIm 0.917, Reproducibility (total) SD 0.039 (CV 4.3%).
HSP2: Mean COIm 1.12, Reproducibility (total) SD 0.048 (CV 4.3%).
HSP3: Mean COIm 2.24, Reproducibility (total) SD 0.104 (CV 4.6%).
PCll 1: Mean COIm 0.239, Reproducibility (total) SD 0.013 (CV 5.4%).
PC 2: Mean COIm 1.65, Reproducibility (total) SD 0.083 (CV 5.1%).
Reproducibility on MODULAR ANALYTICS E170 analyzer:
HSP1: Mean COIm 0.923, Reproducibility (total) SD 0.031 (CV 3.4%).
HSP2: Mean COIm 1.13, Reproducibility (total) SD 0.035 (CV 3.1%).
HSP3: Mean COIm 2.30, Reproducibility (total) SD 0.091 (CV 4.0%).
PCn 1: Mean COIm 0.213, Reproducibility (total) SD 0.017 (CV 8.0%).
PC 2: Mean COIm 1.67, Reproducibility (total) SD 0.069 (CV 4.2%).
Study type: Cross-reactivity.
Sample size: 211 specimens.
Key results: The specificity of the Elecsys Anti-HAV IgM assay was evaluated against various disease states (ANA, CMV, EBV, HBV, HCV, HIV, HSV, Mumps/Rubeola, Parvo B19, Rubella, Toxoplasmosis, and VZV). Out of 211 tested cross-reactants, 209 showed Elecsys Anti-HAV IgM/Reference as Neg/Neg. There was one instance of Elecsys Anti-HAV IgM/Reference Equivocal/Neg (Elevated IgM) and one instance of Elecsys Anti-HAV IgM/Reference Neg/Equivocal (ANA). No instances of Elecsys Anti-HAV IgM/Reference Pos/Pos were observed. HAMA effect was also tested with 10 human serum samples, and no HAMA effect was found.
Study type: Potentially Interfering Substances.
Key results: The assay is unaffected by icterus (bilirubin 15% difference.
Borderline specimens: For Li-heparin, Na-heparin, and K2-EDTA, all 15 borderline specimens showed recovery to serum within
§ 866.3310 Hepatitis A virus (HAV) serological assays.
(a)
Identification. HAV serological assays are devices that consist of antigens and antisera for the detection of hepatitis A virus-specific IgM, IgG, or total antibodies (IgM and IgG), in human serum or plasma. These devices are used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis to determine if an individual has been previously infected with HAV, or as an aid to identify HAV-susceptible individuals. The detection of these antibodies aids in the clinical laboratory diagnosis of an acute or past infection by HAV in conjunction with other clinical laboratory findings. These devices are not intended for screening blood or solid or soft tissue donors.(b)
Classification. Class II (special controls). The special control is “Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays.” See § 866.1(e) for the availability of this guidance document.
0
JUN 2 2 2010
SUBMITTED BY:
Kelly French Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 Phone: (317) 521-3208 Fax: (317) 521-2324 Email: kelly.french@roche.com
NAME OF DEVICE:
Trade Name:
Common Name:
Elecsys® Anti-HAV IgM Elecsys® PreciControl anti-HAV IgM
Anti-HAV IgM Test System PreciControl anti-HAV IgM
Classification Name:
Anti-HAV IgM Test System Quality Control Material (Assayed and Unassayed)
Product Code:
LOL, JJX
Abbott Axsym HAVAB-M 2.0 Assay (P790019/S011)
DEVICE DESCRIPTION:
Predicate Device:
Intended Use: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection.
Assay results, in coniunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis A infection.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Kit Description: The Elecsys Anti-HAV IgM immunoassay utilizes a u-capture test concept based on a monoclonal h-IgM directed biotinylated antibody, cell culture derived Hepatitis A Virus and a ruthenylated monoclonal antibody directed to HAV. Capture of formed immune complexes from the reaction mixture is based on biotin binding to streptavidin-coated magnetic microparticles which are collected on a measuring cell electrode. Signal generation is triggered by the application of a voltage to the electrode (electrochemiluminescence technology). The level of signal count detected by the system increases as the concentration of the IgM antibody target present in a patient sample increases.
1
The Elecsys PreciControl Anti-HAV IgM contains control serum based on human serum in the negative and positive concentration range. The controls are used for monitoring the accuracy of the Elecsys Anti-HAV IgM immunoassays.
| Table 1. Anti-HAV IgM Immunoassay Comparison | ||
|---|---|---|
| Feature | Elecsys Anti-HAV IgM Assay | Predicate Device |
| Abbott Axsym HAVAB-M 2.0 | ||
| Assay (P790019/S011 | ||
| Assay Protocol | μ-Capture test principle | Direct Binding principle |
| Detection Protocol | Electrochemiluminescence | |
| immunoassay (ECLIA) | MEIA | |
| Traceability/ | ||
| Standardization | Roche Internal Standard | Not Given |
| Sample Type | Human serum and plasma | Same |
| Instrument | ||
| Platform | Elecsys 2010 | |
| (Request for CLIA categorization | ||
| has been made to add the | ||
| MODULAR ANALYTICS E170, | ||
| cobas e 411, and cobas e 601 | ||
| analyzers according to the | ||
| Replacement Reagent and | ||
| Instrument Policy). | AxSYM System | |
| Interpretation of | ||
| Results | $\ge$ 1.10 Reactive | |
| $\ge$ 0.90 - $$ 1.20 Reactive | ||
| 0.80 -1.20 Grayzone | ||
| $ 80 | Female | 0 |
| Male | 0 | |
| un- | Female | 0 |
| known | Male | 0 |
| All ages | Female | 0 |
T
The prevalence rate for reactive anti-HAV IgM antibody in specimens collected in a low
prevalence region, Eastern states of the U.S. (Indiana), was 0.00 %.
5
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Prevalence rate for reactive anti-HAV IgM antibody in specimens collected in a high prevalence region, Western states of the U.S. (New Mexico), was 0.33 %.
PRECISION/REPRODUCIBILITY:
Precision and Reproducibility were determined using Elecsys reagents, human sera, and controls. Precision results were collected on three Elecsys 2010 analyzers using a single lot of reagent. PreciControl Anti-HAV IgM 1 and 2 (PC1 and PC2) materials and three human serum pools (high negative HSP1, low positive HSP2 and moderately positive HSP3) were tested in replicates of 2 in 2 runs/day for 20 days according to the CLSI EP15-A2/EP5-A2.
| Precision on Elecsys 2010 analyzer | ||||||
|---|---|---|---|---|---|---|
| Repeatabilityf | Intermediate precisiong | |||||
| Sample | Mean | SD | CV | SD | CV | |
| COI | COI | % | COI | % | ||
| HSP1 | 0.884 | 0.018 | 2.1 | 0.035 | 4.0 | |
| HSP2 | 1.14 | 0.030 | 2.6 | 0.051 | 4.5 | |
| HSP3 | 2.23 | 0.060 | 2.7 | 0.094 | 4.2 | |
| PC A-HAVIGM1 | 0.230 | 0.004 | 1.5 | 0.009 | 4.1 | |
| PC A-HAVIGM2 | 2.04 | 0.050 | 2.5 | 0.098 | 4.8 |
-
Repeatability = within-run precision
-
Intermediate precision = between-run and between-day variation
7
| Precision on MODULAR ANALYTICS E170 analyzers | |||||
|---|---|---|---|---|---|
| Repeatabilityh | Intermediate precisioni | ||||
| Sample | Mean | SD | CV | SD | CV |
| COI | COI | % | COI | % | |
| HSP1 | 0.929 | 0.018 | 1.9 | 0.040 | 4.4 |
| HSP2 | 1.22 | 0.024 | 2.0 | 0.060 | 4.9 |
| HSP3 | 2.36 | 0.052 | 2.2 | 0.110 | 4.7 |
| PC A-HAVIGM1 | 0.217 | 0.005 | 2.3 | 0.010 | 4.5 |
| PC A-HAVIGM2 | 2.13 | 0.043 | 2.0 | 0.110 | 5.1 |
h) Repeatability = within-run precision
- Intermediate precision = between-run and between-day variation
Reproducibility was performed on three external sites on three different Elecsys 2010 and cobas e 411 analyzers. Three human serum pools (high negative HSP3, low positive HSP1 and moderately positive HSP2) were tested in replicates of 3 in 2 runs/day for 5 days according to the CLSI EP15-A2/EP5-A2.
| Reproducibility on Elecsys 2010 analyzer | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Repeat- | |||||||||||
| abilityj | Inter- | ||||||||||
| mediate | |||||||||||
| precisionk | Between- | ||||||||||
| day | Between- | ||||||||||
| site | Repro- | ||||||||||
| ducibility (total) | |||||||||||
| Sample | Mean | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| COIm | COI | % | COI | % | COI | % | COI | % | COI | % | |
| HSP1 | 0.917 | 0.031 | 3.4 | 0.007 | 0.8 | 0.003 | 0.3 | 0.023 | 2.5 | 0.039 | 4.3 |
| HSP2 | 1.12 | 0.034 | 3.0 | 0.024 | 2.1 | 0.000 | 0.0 | 0.025 | 2.2 | 0.048 | 4.3 |
| HSP3 | 2.24 | 0.086 | 3.8 | 0.050 | 2.2 | 0.000 | 0.0 | 0.029 | 1.3 | 0.104 | 4.6 |
| PCll 1 | 0.239 | 0.006 | 2.6 | 0.000 | 0.0 | 0.004 | 1.9 | 0.010 | 4.4 | 0.013 | 5.4 |
| PC 2 | 1.65 | 0.049 | 3.0 | 0.021 | 1.3 | 0.058 | 3.5 | 0.027 | 1.6 | 0.083 | 5.1 |
- Repeatability = within-run precision
k) Intermediate precision = between-run
- SD = standard deviation
m) COI = cutoff index
") PC = PreciControl A-HAVIGM
8
| Reproducibility on MODULAR ANALYTICS E170 analyzer | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | Mean | ||||||||||
| COIm | Repeat- | ||||||||||
| abilityj | |||||||||||
| SD | |||||||||||
| COI | CV | ||||||||||
| % | Intermediate | ||||||||||
| precisionk | |||||||||||
| SD | |||||||||||
| COI | CV | ||||||||||
| % | Between- | ||||||||||
| day | |||||||||||
| SD | |||||||||||
| COI | CV | ||||||||||
| % | Between- | ||||||||||
| site | |||||||||||
| SD | |||||||||||
| COI | CV | ||||||||||
| % | Repro- | ||||||||||
| ducibility (total) | |||||||||||
| SD | |||||||||||
| COI | CV | ||||||||||
| % | |||||||||||
| HSP1 | 0.923 | 0.019 | 2.1 | 0.020 | 2.1 | 0.000o | 0.0 | 0.014 | 1.5 | 0.031 | 3.4 |
| HSP2 | 1.13 | 0.026 | 2.3 | 0.024 | 2.1 | 0.000o | 0.0 | 0.000o | 0.0 | 0.035 | 3.1 |
| HSP3 | 2.30 | 0.046 | 2.0 | 0.078 | 3.4 | 0.000o | 0.0 | 0.000o | 0.0 | 0.091 | 4.0 |
| PCn 1 | 0.213 | 0.004 | 1.9 | 0.000o | 0.0 | 0.001 | 0.4 | 0.016 | 7.7 | 0.017 | 8.0 |
| PC 2 | 1.67 | 0.048 | 2.9 | 0.047 | 2.8 | 0.000o | 0.0 | 0.018 | 1.1 | 0.069 | 4.2 |
] Repeatability = within-run precision
k) Intermediate precision = between-run
- SD = standard deviation
™ COI = cutoff index
") PC = PreciControl A-HA VIGM
® SD of zero due to variance contributed by particular component was below stated significant figure.
9
CROSS-REACTIVITY:
The specificity of the Elecsys Anti-HAV IgM assay was evaluated by testing a total of 211 specimens representing a variety of disease states (ANA, CMV, EBV, HBV, HCV, HIV, HSV, Mumps/Rubeola, Parvo B19, Rubella, Toxoplasmosis, and VZV).
| Cross- reactant | No.
tested | Elecsys Anti-
HAV IgM/
Reference
Neg/Neg | Elecsys Anti-
HAV IgM/
Reference
Equivocal/ Neg | Elecsys Anti-
HAV IgM/
Reference Neg/
Equivocal | Elecsys Anti-
HAV IgM/
Reference
Pos/Pos |
|-------------------|---------------|---------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------|
| ANA | 11 | 10 | 0 | 1 | 0 |
| CMV | 13 | 13 | 0 | 0 | 0 |
| EBV | 16 | 16 | 0 | 0 | 0 |
| Elevated IgG | 13 | 13 | 0 | 0 | 0 |
| Elevated IgM | 12 | 11 | 1 | 0 | 0 |
| HBV | 20 | 20 | 0 | 0 | 0 |
| HCV | 11 | 11 | 0 | 0 | 0 |
| HIV | 11 | 11 | 0 | 0 | 0 |
| HSV | 11 | 11 | 0 | 0 | 0 |
| Mumps/ Rubeola | 15 | 15 | 0 | 0 | 0 |
| Parvo B19 | 15 | 15 | 0 | 0 | 0 |
| Rheumatoid factor | 12 | 12 | 0 | 0 | 0 |
| Rubella | 20 | 20 | 0 | 0 | 0 |
| Toxoplasmosis | 16 | 16 | 0 | 0 | 0 |
| VZV | 15 | 15 | 0 | 0 | 0 |
| Total | 211 | 209 | 1 | 1 | 0 |
The testing results are summarized in the table below.
HAMA effect was tested by comparing the recovery of 10 human serum samples spiked with HAMA versus 10 unspiked aliquots of samples. No HAMA effect was found.
10
POTENTIALLY INTERFERING SUBSTANCES:
The assay is unaffected by icterus (bilirubin 15 % |
| Li-heparin | 9 | 1 | 0 |
| Na-heparin | 9 | 1 | 0 |
| K2-EDTA | 10 | 0 | 0 |
| Sodium citrate | 9 | 1 | 0 |
11
| Plasma matrix | Number of borderline specimens showing recovery to serum within various ranges | ||
|---|---|---|---|
| 15 % | |||
| Li-heparin | 15 | 0 | 0 |
| Na-heparin | 15 | 0 | 0 |
| K2-EDTA | 15 | 0 | 0 |
| Sodium citrate | 12 | 3 | 0 |
| Plasma matrix | Number of negative specimens showing recovery to serum within
various ranges | | |
|----------------|---------------------------------------------------------------------------------|---------------|-----------|
| | 0.3 COI |
| Li-heparin | 20 | 0 | 0 |
| Na-heparin | 20 | 0 | 0 |
| K2-EDTA | 20 | 0 | 0 |
| Sodium citrate | 20 | 0 | 0 |
12
Image /page/12/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center -- WO66-0609 Silver Spring, MD 20993-0002
Ms. Kelly French, RN, BSN, RAC Regulatory Affairs Consultant Roche Diagnostics Roche Professional Diagnostics 9115 Hague Road Indianapolis, IN 46250-0416
JUN 2 2 2010
Re: K093955
| Trade/Device Name: | Elecsys® Anti-HAV IgM
Elecsys® PreciControl Anti-HAV IgM |
|--------------------|------------------------------------------------------------------|
| Regulation Number: | 21 CFR §866.3310
21 CFR §862.1660 |
| Regulation Name: | Hepatitis A Virus Serological Assays
Quality Control Material |
| Regulatory Class: | Class II |
| Product Code: | LOL
JJX |
| Dated: | March 23, 2010 |
| Received: | March 24, 2010 |
Dear Ms. French:
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. Iisting 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Uue Scif Ar
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
14
Indication for Use
510(k) Number: K093955
Device Name: Elecsys Anti-HAV IgM Assay
Indication For Use:
The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection.
Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis A infection.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Device Name: Elecsys Anti-HAV IgM PreciControl
Indication For Use:
Elecsys PreciControl Anti-HAV IgM is used for quality control of the Elecsys Anti-HAV IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Uve Schly
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093955