← Product Code [LSR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR) · K161513

# Anti-Borrelia burgdorferi US Westernblot (IgG) (K161513)

_Euroimmun US · LSR · Aug 25, 2016 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K161513

## Device Facts

- **Applicant:** Euroimmun US
- **Product Code:** [LSR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR.md)
- **Decision Date:** Aug 25, 2016
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3830
- **Device Class:** Class 2
- **Review Panel:** Microbiology
- **Attributes:** Software as a Medical Device

## Indications for Use

The EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG) kit is a Western blot assay intended for the qualitative determination of IgG class antibodies against Borrelia burgdorferi in human serum and plasma (K⁺-EDTA, Li⁺-heparin, Na⁺-citrate) samples that have been found positive or equivocal/borderline using an enzyme immunoassay (EIA) or immunofluorescence assay (IFA) test procedure for Borrelia burgdorferi antibodies. Results can be read manually or automated utilizing EUROLineScan. This test is used as an aid in the diagnosis of infections with B. burgdorferi and the associated diseases, in conjunction with other laboratory and clinical findings.

## Device Story

Western blot assay for qualitative detection of IgG antibodies against Borrelia burgdorferi. Input: human serum or plasma samples (K+-EDTA, Li+-heparin, Na+-citrate) previously screened as positive/equivocal by EIA/IFA. Process: patient samples incubated with test strips containing electrophoretically separated B. burgdorferi antigens; specific IgG antibodies bind to antigens; enzyme-labeled anti-human IgG conjugate added; color reaction catalyzed by substrate. Output: visual or automated (EUROLineScan) identification of specific protein bands on nitrocellulose membrane. Used in clinical laboratories; interpreted by technicians or software according to CDC criteria. Results aid diagnosis of Lyme disease in conjunction with clinical findings.

## Clinical Evidence

No clinical data provided in the document.

## Technological Characteristics

Western blot assay using B. burgdorferi (strain B31) antigens separated by SDS-PAGE and transferred to nitrocellulose membranes. Detection uses alkaline phosphatase anti-human IgG conjugate and NBT/BCIP substrate. Qualitative format. Manual or automated (EUROLineScan) reading. Compatible with serum and plasma (K+-EDTA, Li+-heparin, Na+-citrate).

## Regulatory Identification

Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

1

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION MEMORANDUM

A. 510(k) Number: K161513
B. Purpose for Submission: To obtain a substantial equivalence determination and FDA clearance for a new device
C. Measurand: Anti-Borrelia burgdorferi (IgG) antibodies
D. Type of Test: Enzyme Immunoassay
E. Applicant: EUROIMMUN US
F. Proprietary and Established Names: EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG)

## G. Regulatory Information:

1. Regulation section: 21 CFR 866.3830; Treponema pallidum treponemal test reagents
2. Classification: Class II
3. Product code: LSR; Reagent, Borrelia Serological Reagent
4. Panel: Microbiology

## H. Intended Use:

1. Intended use(s): The EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG) kit is a Western blot assay intended for the qualitative determination of IgG class antibodies against Borrelia burgdorferi in human serum and plasma (K⁺-EDTA, Li⁺-heparin, Na⁺-citrate) samples that have been found positive or equivocal/borderline using an enzyme immunoassay (EIA) or immunofluorescence assay (IFA) test procedure for Borrelia burgdorferi antibodies. Results can be read manually or automated utilizing EUROLineScan. This test is used as an aid in the diagnosis of infections with B. burgdorferi and the associated diseases, in conjunction with other laboratory and clinical findings.
2. Indication(s) for use: Same as Intended Use
3. Special conditions for use statement(s): N/A
4. Special instrument requirements: N/A

{1}

I. Device Description: The test kit contains test strips with electrophoretically separated antigen extracts of B. burgdorferi. The blot strips will be blocked and incubated in the first reaction step with diluted patient samples. In the case of positive samples, specific antibodies of the class IgG (and IgA, IgM) will bind to the antigens. To detect the bound antibodies, a second incubation is carried out using an enzyme-labelled anti-human IgG (enzyme conjugate), catalyzing a color reaction.

J. Substantial Equivalence Information:

1. Predicate device name(s): MarDx Lyme Disease (IgG) Marblot Strip Test System
2. Predicate 510(k) number(s): K950829
3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | New Device | Predicate device  |
|  Intended Use | Detection of IgG antibodies to Borrelia burgdorferi | Same  |
|  Assay format | Qualitative | Same  |
|  Technology/Procedure | Serum incubation with antigen coated strips followed by a wash step, incubation with an anti-human IgG enzyme conjugate; wash step, incubation with substrate, wash step, air drying and visual reading. | Same  |
|  Antigens | Antigens of Borrelia Burgdorferi (strain B31) are separated in the presence of sodium dodecyl sulfate (SDS) by polyacrylamide gel electrophoresis. The resolved protein bands are then transferred to a nitrocellulose membrane. | Same  |
|  Conjugate | Alkaline phosphatase anti-human IgG | Same  |
|  Substrate | NBT/BCIP | Same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | New Device | Predicate device  |
|  Sample | 30 μl Serum or Plasma
1:51 dilution | 20 μl Serum
undiluted  |
|  Incubation times | 30 – 30 – 10 min | 30 – 15 – (4 - 12) min  |
|  Controls | Evaluation matrix with control strip (test strip incubated with a positive control serum) | Serum band locator
Weakly reactive control
Negative control  |

K. Standard/Guidance Document Referenced (if applicable): N/A
L. Test Principle: Enzyme Immunoassay
M. Performance Characteristics (if/when applicable):

{2}

1. Analytical performance:

a. Precision/Reproducibility:

Precision/Repeatability: Repeatability was investigated by repeated determinations of 7 native characterized samples. [Negative (samples 1 and 2), low positive (sample 3), and moderate positive (samples 4, 5, 6 and 7)]. The samples were tested on 4 different days with 2 runs per day, 2 reps per run according to the package insert. No positive sample was found negative and vice versa.

|  n = 16 | EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Sample 1 | Sample 2 | Sample 3 | Sample 4 | Sample 5 | Sample 6 | Sample 7  |
|  Characterization | negative | negative | positive | positive | positive | positive | positive  |
|  % negative | 100.0% | 100.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0%  |
|  % positive | 0.0% | 0.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0%  |
|  Band(s) | EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG)  |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  p18/21 | p25 | p28 | p30 | p39 | p41 | p45 | p58 | p66 | p83/93  |
|  Sample 1 | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 100.0% | 0.0% | 0.0% | 0.0% | 0.0%  |
|  Sample 2 | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 81.3% | 0.0%  |
|  Sample 3 | 75.0% | 0.0% | 0.0% | 0.0% | 100.0% | 100.0% | 100.0% | 0.0% | 100.0% | 100.0%  |
|  Sample 4 | 87.5% | 81.3% | 0.0% | 0.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 0.0%  |
|  Sample 5 | 100.0% | 87.5% | 75.0% | 0.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 0.0%  |
|  Sample 6 | 81.3% | 81.3% | 0.0% | 0.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 0.0%  |
|  Sample 7 | 100.0% | 0.0% | 68.8% | 50.0% | 100.0% | 100.0% | 0.0% | 100.0% | 100.0% | 100.0%  |

Reproducibility: Reproducibility was investigated by repeated determinations of 7 native characterized samples. [Negative (samples 1 and 2), low positive (sample 3), and moderate positive (samples 4, 5, 6 and 7)]. The samples were tested on 4 different days with 2 runs per day, 2 reps per run at 3 different sites according to the package insert. No positive sample was found negative and vice versa.

|  n = 48 | EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Sample 1 | Sample 2 | Sample 3 | Sample 4 | Sample 5 | Sample 6 | Sample 7  |
|  Characterization | negative | negative | positive | positive | positive | positive | positive  |
|  % negative | 100.0% | 100.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0%  |
|  % positive | 0.0% | 0.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0%  |
|  Band(s) | EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG)  |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  p18/21 | p25 | p28 | p30 | p39 | p41 | p45 | p58 | p66 | p83/93  |
|  Sample 1 | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 100.0% | 0.0% | 0.0% | 0.0% | 0.0%  |
|  Sample 2 | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 81.3% | 0.0%  |
|  Sample 3 | 87.5% | 0.0% | 0.0% | 0.0% | 100.0% | 100.0% | 97.9% | 0.0% | 100.0% | 100.0%  |
|  Sample 4 | 91.7% | 85.4% | 0.0% | 0.0% | 97.9% | 100.0% | 100.0% | 97.9% | 100.0% | 0.0%  |
|  Sample 5 | 93.8% | 87.5% | 81.3% | 0.0% | 100.0% | 100.0% | 100.0% | 97.9% | 100.0% | 0.0%  |
|  Sample 6 | 89.6% | 85.4% | 0.0% | 0.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 0.0%  |
|  Sample 7 | 100.0% | 0.0% | 81.3% | 50.0% | 97.9% | 100.0% | 0.0% | 100.0% | 100.0% | 100.0%  |

{3}

b. Linearity/assay reportable range: N/A
c. Traceability, Stability, Expected values (controls, calibrators, or methods): N/A
d. Detection limit: N/A
e. Analytical specificity:

Normal Population Study: Testing of samples from an asymptomatic population in both endemic and non-endemic regions was performed. The levels of anti- $B$ . burgdorferi antibodies were analyzed with the EUROIMMUN Anti-Borrelia burgdorferi US Western blot (IgG) in a panel of 98 samples from an endemic region (Pennsylvania; 89 men and 9 women with an average age of 34 y; age range: 18 - 56 y) and in a panel of 100 samples from a non-endemic region (Tennessee; 82 men and 18 women with an average age of 38 y; age range: 3 - 62 y).  $3.1\%$  of the samples from the endemic region were found positive for anti- $B$ . burgdorferi (IgG), whereas none of the samples from the non-endemic region were positive.

|  Panel | n | EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG)  |   |
| --- | --- | --- | --- |
|   |   |  positive (%) | negative (%)  |
|  Endemic: Pennsylvania | 98 | 3 | 97 (96.9%)  |
|  Non-endemic: Tennessee | 100 | 0 | 100 (100%)  |

Cross Reactivity: Cross reactivity was investigated using characterized samples from the following groups shown in the table below. All the samples tested were found negative with the EUROIMMUN Anti-Borrelia burgdorferi US Western blot (IgG) according to the CDC criteria.

|  Panel | n | EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG)  |
| --- | --- | --- |
|   |   |  negative (%)  |
|  EBV | 15 | 15 (100.0%)  |
|  HSV | 14 | 14 (100.0%)  |
|  Influenza viruses | 15 | 15 (100.0%)  |
|  H. pylori | 11 | 11 (100.0%)  |
|  Measles | 15 | 15 (100.0%)  |
|  Parvovirus B19 | 12 | 12 (100.0%)  |
|  Rubella | 14 | 14 (100.0%)  |
|  Treponema | 10 | 10 (100.0%)  |
|  CMV | 10 | 10 (100.0%)  |
|  Babesiosis | 3 | 3 (100.0%)  |

{4}

5

|  Panel | n | EUROIMMUN
Anti-Borrelia burgdorferi US
Westernblot (IgG)  |
| --- | --- | --- |
|   |   |  negative (%)  |
|  Anaplasmosis
(ehrlichiosis) | 10 | 10 (100.0%)  |
|  Rickettsial diseases | 4 | 4 (100.0%)  |
|  Rheumatoid arthritis | 22 | 22 (100.0%)  |
|  Total | 155 | 155 (100.0%)  |

Note: The results obtained with babesiosis (3) and ricketsial diseases (4) samples are not conclusive as enough samples were not tested.

Interferences: Hemolytic, lipemic and icteric samples showed no influence at the result up to a concentration of 500 mg/dl for hemoglobin, 2000 mg/dl for triglycerides and 40 mg/dl for bilirubin in this test system. Interferences with albumin, intralipids, and cholesterol have not been investigated.

f. Assay cut-off:

The cut-off of the EUROLINE-WB test system is defined as the lowest limit of a clearly visible band. Because visual examination by the operator might be subjective, the reaction control card was developed to standardize strip evaluation. Alternatively the EUROLineScan software was established to allow for automated evaluation.

2. Comparison studies:

a. Method comparison with predicate device:

Prospective Study: A prospective study was performed at 3 different sites. All samples were initially tested with a FDA cleared first-step EIA. All ELISA positive and equivocal/borderline samples were then tested with the EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG) and the predicate IgG Western blot. Results from the test device and the predicate Western blot are interpreted by the CDC criteria.

|  n = 304 | Predicate IgG WB  |   |   |
| --- | --- | --- | --- |
|   |   |  positive | negative  |
|  EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG) | positive | 233 | 6  |
|   |  negative | 8 | 57  |

Negative agreement: 57/63 = 90.5%
Positive agreement: 233/241 = 96.7%
95% C.I.: 80.4% - 96.4%
95% C.I.: 93.6% - 98.6%

{5}

b. Matrix comparison:

Serum/Plasma Comparison: The use of  $\mathrm{K}^+$ -EDTA,  $\mathrm{Li}^+$ -heparin and  $\mathrm{Na}^+$ -citrate plasma samples were confirmed by a correlation of 20 sample sets of serum and corresponding plasma. The sample sets were selected to cover both negative and positive results. The results of the plasma samples and the corresponding serum sample were compared and found to be equivalent as no positive sample was found negative and vice versa.

# 3. Clinical studies:

# a. Clinical Sensitivity:

Sensitivity Study: A study, consisting of 101 clinically characterized Lyme disease specimens, was conducted at the manufacturer's site with the EUROIMMUN Anti-Borrelia burgdorferi US Western blot (IgG) test device in parallel with the predicate device. The clinically characterized specimens encompassed samples from early, early disseminated, and late phases of the disease. (Initial (acute) and Convalescent samples from patients with documented erythema migrans (EM); and of known Lyme disease patients with presentations other than EM, e.g., neuro-, arthritic, etc.) The panel consisted of 35 men, 58 women and 8 unknowns. The age ranged from 16 - 87 years with a mean age of 45 years.

|  Interval | n | EUROIMMUN Anti-Borrelia US Westernblot (IgG) burgdorferi |   | Predicate IgG WB  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  positive | % | positive | %  |
|  <1 month | 11 | 6 | 54.5% | 5 | 45.5%  |
|  >1-3 months | 23 | 13 | 56.5% | 9 | 39.1%  |
|  >3-12 months | 38 | 25 | 65.8% | 7 | 18.4%  |
|  >12 months | 29 | 12 | 41.4% | 9 | 31.0%  |
|  Overall | 101 | 56 | 55.4% | 30 | 29.7%  |

# Clinical Sensitivity:

EUROIMMUN Westernblot (IgG):  $56 / 101 = 55.4\%$  95% C.I.: 45.2% - 65.3%

Predicate IgG WB:  $30 / 101 = 29.7\%$  95% C.I.: 21.0% - 39.6%

CDC Panel Testing: 34 sera of patients with clinically characterized borreliosis in different disease stages and 5 normals, obtained from the Centers for Disease Control and Prevention, Atlanta, GA, USA, were tested with the EUROIMMUN Anti-Borrelia burgdorferi US Western blot (IgG) in parallel with the predicate device.

{6}

7

|  Interval | n | EUROIMMUN Anti-Borrelia US Westernblot (IgG) burgdorferi |   | Predicate IgG WB  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  positive | % | positive | %  |
|  Normals | 5 | 0 | 0.0% | 0 | 0.0%  |
|  <1 month | 6 | 3 | 50.0% | 3 | 50.0%  |
|  >1-3 months | 10 | 2 | 20.0% | 2 | 20.0%  |
|  >3-12 months | 12 | 5 | 41.7% | 5 | 41.7%  |
|  >12 months | 6 | 6 | 100.0% | 6 | 100.0%  |
|  Overall | 39 | 16 | 41.0% | 16 | 41.0%  |

Note: The results are presented as a means to convey further information on the performance of this assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC.

## EUROLineScan vs. Visual Read

The use of the EUROLineScan reader and software compared to visual reading was investigated using 111 characterized samples. Evaluation was performed both visually using the reaction control card and automatically using the EUROLineScan software. The results of the EUROLineScan interpretation and of the visual evaluation by three different technicians are shown in the tables below. Results of the two evaluation methods were found to be in line. Overall correlation between Readers 1 &amp; 3 was 100% and 97.3% between Reader 1 and 3 to Reader 2. Evaluation of the results is performed according to the CDC criteria.

|  n = 111 | EUROIMMUN Anti-Borrelia burgdorferi US EUROLINE-WB (IgG) Visual Interpretation  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  Reader 1 |   | Reader 2 |   | Reader 3  |   |
|   |   |  pos | neg | pos | neg | pos | neg  |
|  EUROIMMUN Anti-Borrelia burgdorferi US EUROLINE-WB (IgG) EUROLineScan Interpretation | pos | 50 | 0 | 50 | 0 | 50 | 0  |
|   |  neg | 0 | 61 | 3 | 58 | 0 | 61  |
|  Reader 1 vs EUROLINE Scan  |   |   |   |   |   |   |   |
|  Negative agreement | 61 / 61 = 100.0% |   |   | 95% C.I.: 92.3% - 100.0%  |   |   |   |
|  Positive agreement | 50 / 50 = 100.0% |   |   | 95% C.I.: 91.5% - 100.0%  |   |   |   |
|  Overall agreement | 111 / 111 = 100.0% |   |   | 95% C.I.: 96.0% - 100.0%  |   |   |   |
|  Reader 2 vs EUROLINE Scan  |   |   |   |   |   |   |   |
|  Negative agreement | 58 / 58 = 100.0% |   |   | 95% C.I.: 92.6% - 100.0%  |   |   |   |
|  Positive agreement | 50 / 53 = 94.3% |   |   | 95% C.I.: 84.0% - 98.7%  |   |   |   |
|  Overall agreement | 108 / 111 = 97.3% |   |   | 95% C.I.: 92.0% - 99.4%  |   |   |   |
|  Reader 3 vs EUROLINE Scan  |   |   |   |   |   |   |   |
|  Negative agreement | 61 / 61 = 100.0% |   |   | 95% C.I.: 92.3% - 100.0%  |   |   |   |
|  Positive agreement | 50 / 50 = 100.0% |   |   | 95% C.I.: 91.5% - 100.0%  |   |   |   |
|  Overall agreement | 111 / 111 = 100.0% |   |   | 95% C.I.: 96.0% - 100.0%  |   |   |   |

{7}

b. Clinical specificity: N/A
c. Other clinical supportive data (when a. and b. are not applicable): N/A

4. Clinical cut-off: N/A
5. Expected values/Reference range:

Expected Values: The range of values and positivity of different populations among different studies are presented below with available patient demographics.

|  Population | n | Sex | Mean Age & Range | EUROIMMUN Anti-Borrelia burgdorferi US Western blot (IgG)  |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |   |  p18/21 | p25 | p28 | p30 | p39 | p41 | p45 | p58 | p66 | p83/93 | Anti-B. burgd. positive (%)  |

Prospective Study

|  EIA Positive | 304 | 169 men, 133 women, 2 unknown | 56 yrs 4 - 88 yrs 4 unknown | 239 | 197 | 111 | 130 | 251 | 297 | 184 | 190 | 176 | 190 | 233 (76.6%)  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

Lyme Disease

|  Sensitivity Study | 101 | 35 men, 58 women, 8 unknown | 45 yrs 16 - 87 yrs 9 unknown | 47 | 33 | 5 | 31 | 49 | 96 | 27 | 28 | 49 | 28 | 56 (55.4%)  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

Normal Population Study

|  Endemic | 98 | 89 men, 9 women | 34 yrs 18 - 56 yrs | 10 | 3 | 1 | 7 | 4 | 84 | 6 | 14 | 14 | 10 | 3 (3.1%)  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Non- Endemic | 100 | 82 men, 18 women | 38 yrs 3 - 62 yrs | 9 | 2 | 0 | 13 | 2 | 87 | 4 | 5 | 16 | 8 | 0 (0.0%)  |

Note: It is recommended that each laboratory determine its own normal range based on the population and equipment used.

N. Software:

FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types:

Yes ☐ X ☐ or No ☐

O. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

P. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K161513](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K161513)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com