← Product Code [JKA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA) · K093910

# IMPROVACUTER GEL & CLOT ACTIVATOR TUBE (K093910)

_Guangzhou Improve Medical Instruments Co., Ltd. · JKA · Jul 12, 2010 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA/K093910

## Device Facts

- **Applicant:** Guangzhou Improve Medical Instruments Co., Ltd.
- **Product Code:** [JKA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA.md)
- **Decision Date:** Jul 12, 2010
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1675
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

IMPROVACUTER Gel & Clot Activator Tube is a single used to collect, transport, separate, and process venous blood specimens to obtain serum for clinical chemistry and immunology assays. It is used in settings where a venous blood sample is collected by a trained healthcare worker. For in vitro diagnostic use.

## Device Story

Sterile, plastic, evacuated blood collection tube; contains silica clot activator and barrier gel. Operates via controlled vacuum to draw specific venous blood volume; inverted 5-8 times for mixing; allowed to clot (min 30 mins); centrifuged (1500-2200 RCF) to move gel to serum-clot interface. Used in clinical settings by trained healthcare workers. Serum aspirated directly from tube. Facilitates serum separation for clinical chemistry/immunology assays; eliminates transfer steps. Benefits include rapid clotting and efficient serum separation.

## Clinical Evidence

Bench testing only. Method comparison studies conducted at two hospital sites with 252 total adult subjects (127 and 125). Evaluated 41 analytes across multiple platforms (Roche Modular PPI, Beckman DxC 800, Abbott I2000, etc.). Linear regression slopes ranged from 0.9503 to 1.0155. Qualitative serological tests (CMV IgG/IgM, VZV-IgG) showed 100% agreement. Precision studies (within-lot and between-lot) performed on representative platforms; CVs generally <5%. Analyte stability confirmed for 24 hours at 2-8°C and 22-25°C (except TBIL, stable to 20 hours).

## Technological Characteristics

Sterile, plastic, evacuated tube (13x75mm, 13x100mm). Contains silica clot activator and barrier gel polymer. Vacuum-based blood draw. Sterilized via radiation (ISO 11137). Complies with CLSI H1-A5, H3-A6, H18-A3.

## Regulatory Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

## Predicate Devices

- BD Vacutainer® Gel & Clot Activator Tube (plastic) ([K023075](/device/K023075.md))

## 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/).

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k093910

B. Purpose for Submission:
New device

C. Measurand:
Not applicable - blood collection system

D. Type of Test:
Not applicable

E. Applicant:
Guangzhou Improve Medical Instruments Co., Ltd.

F. Proprietary and Established Names:
IMPROVACUTER® Gel &amp; Clot Activator Tube

G. Regulatory Information:
1. Regulation section:
21CFR 862.1675 (Blood specimen collection devices)
2. Classification:
Class II
3. Product code:
JKA
4. Panel:
75 (Chemistry)

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H. Intended Use:

1. Intended use(s):

See Indication for use below

2. Indication(s) for use:

IMPROVACUTER Gel &amp; Clot Activator Tube is a single use tube used to collect, transport, separate, and process venous blood specimens to obtain serum for clinical chemistry and immunology assays. It is used in settings where a venous blood sample is collected by a trained healthcare worker. For in vitro diagnostic use.

3. Special conditions for use statement(s):

Prescription Use only.

These blood collection tubes are not recommended for Therapeutic drug monitoring (TDM), blood banking and infectious disease testing.

4. Special instrument requirements:

Specific analyzers used to evaluate the device are listed in the labeling and below in section M. 2. a. method comparison.

I. Device Description:

The IMPROVACUTER Gel &amp; Clot Activator Tube is sterile, plastic, evacuated blood collection tube. The tube consists of (1) a closure assembly, (2) a silica clot activator, (3) a barrier gel and (4) a plastic tube. The specimens are used for clinical laboratory assays involving the use of patient serum.

The IMPROVACUTER Gel &amp; Clot Activator Tube is a 13 x 100 mm, 5.0 mL, and plastic evacuated tube with either a gold conventional closure or a gray safety cap. The interior of the tube wall is coated with clot activator to promote rapid clotting. The tube contains a gel barrier polymer at the tube bottom. The density of this material causes it to move upward during centrifugation to the serum-clot interface, where it forms a barrier separating serum from the clot. Serum may be aspirated directly from the collection tube, eliminating the need to transfer to another container. The tube interior is sterile and the product is for single use only.

J. Substantial Equivalence Information:

1. Predicate device name(s):

BD Vacutainer® Gel &amp; Clot Activator Tube

2. Predicate 510(k) number(s):

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k023075

## 3. Comparison with predicate:

Similarities and Differences between the candidate device and the predicate device

|  Items | BD Vacutainer® Tube (Predicate device-k023075) | Improvacuter Gel & Clot Activator Tube (Candidate device)  |
| --- | --- | --- |
|  Intended use | Single use tube used to collect, separate, transport, and process venous blood specimens to obtain serum for chemistry determinations for in vitro diagnostic use. It is used in settings where a venous blood sample is collected by a trained healthcare worker. | Same  |
|  Limitations | It is recommended for use with Therapeutic drug monitoring. | Not to be used for Therapeutic drug monitoring, blood banking and infectious disease.  |
|  TUBE COMPARISON  |   |   |
|  Tube Dimension | 13 x 75 mm | 13x75 mm, 13 x 100 mm  |
|  Draw Volume | 3.5 mL | 3.0 mL, 5.0 mL  |
|  Closure | Conventional rubber closure | Conventional rubber closure (with and without safety cap)  |
|  Clot Activator | Silica | Same  |
|  Clotting Time | 30 minutes | Same  |
|  Materials | Plastic | Same  |
|  Tube Shelf Life | 12 months | Same  |
|  Tube Sterility | Sterile | Same  |

## K. Standard/Guidance Document Referenced (if applicable):

1. CLSI Guideline H1-A5, Evacuated Tubes and Additives for Venous Blood Specimen Collection
2. CLSI Guideline H3-A6, Procedures for the Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture
3. CLSI Guideline H18-A3, Procedures for the processing and Handling of Blood Specimens
4. ISO 11137-1 Sterilization of Health Care Products Radiation Part 1- Requirements for the

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development, validation and routine control of a sterilization process for medical devices

5. ISO 11137-2 Sterilization of Health Care Products Radiation Part 2- Establishing the sterilization dose
6. ISO 11137-3 Sterilization of Health Care Products Radiation Part 3- Guidance on dosimetric aspects
7. CLSI Guideline EP9-A2, Method Comparison and Bias Estimation Using Patient Samples

# L. Test Principle:

The IMPROVACUTER Gel &amp; Clot Activator Tube (IMP tube) is intended to be placed inside either a holder or an adapter of a blood collection system. Once the vein of the patient has been penetrated using a standard needle, the tube is pushed fully into the needle holder so that the non-patient's end of the needle pierces the rubber septum of the stopper of the tube. The tube uses a controlled vacuum to pull a specific volume of blood into the sterile interior of the tube. The pressure differential caused the venous blood to flow into the tube. Once pressure is equalized, the blood flow ceases and the tube is withdrawn from the needle holder or needle. After blood has been drawn, the tube shall be immediately inverted gently for 5 to 8 times to mix the blood with the additives, and then allowed to clot completely. The recommended minimum clotting time is 30 minutes. Once clotting is complete, the tube is to be centrifuged for 10 minutes (when using a swing bucket centrifuge) or 15 minutes (when using a fixed angle centrifuge), at RCF (g force) of 1500-2200.

# M. Performance Characteristics (if/when applicable):

# 1. Analytical performance:

# a. Precision/Reproducibility:

Precision studies were performed in conjunctions with the method comparison studies at two external hospital sites. Within-lot precision study and between-lot precision study were performed separately. Testing were performed using twenty apparently healthy subjects per study. For within-lot precision study, each subject has a venous blood collection into four tubes: two IMP tubes with the same lot number and two BD tubes with the same lot number. For between-lot precision study, each subject has a venous blood collection into four tubes: two IMP tubes with different lot numbers and two BD tubes with different lot numbers. Each tube was tested in duplicates for each of the 38 analytes and on multiple different instrument platforms. Results (within-lot and between-lot precision) on one representative instrument platform are summarized in the tables below:

Table 1. Within Lot precision on ROCHE PPI for IMP tube

|  No | Analyte/Unit | mean | SD | CV(%) | 95% LCL | 95% UCL  |
| --- | --- | --- | --- | --- | --- | --- |
|  1 | ALT(U/L) | 24.56 | 0.37 | 1.51% | 0.85% | 2.17%  |
|  2 | AST(U/L) | 20.72 | 1.03 | 4.97% | 2.79% | 7.15%  |
|  3 | ALP(U/L) | 62.62 | 2.38 | 3.80% | 2.13% | 5.47%  |

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Table 2. Within Lot precision on Abbott I2000 for IMP tube

|  No | Analyte/Unit | mean | SD | CV(%) | 95% LCL | 95% UCL  |
| --- | --- | --- | --- | --- | --- | --- |
|  32 | Free T4(pmol/L) | 10.98 | 0.35 | 3.19% | 1.79% | 4.59%  |
|  33 | TSH(uIU/ml) | 4.14 | 0.05 | 1.21% | 0.68% | 1.74%  |
|  34 | Prolactin(mIU/L) | 818.52 | 23.53 | 2.87% | 1.61% | 4.13%  |
|  35 | HCG(IU/L) | 1.01 | 0.04 | 3.96% | 2.22% | 5.70%  |
|  36 | Ferritin(ng/ml) | 170.37 | 2.32 | 1.36% | 0.76% | 1.96%  |

Table 3. Within Lot precision on Abbott AxSym for IMP tube

|  No | Analyte/Unit | mean | SD | CV(%) | 95% LCL | 95% UCL  |
| --- | --- | --- | --- | --- | --- | --- |
|  37 | cTnI(ng/ml) | 0.278 | 0.01 | 3.60% | 2.02% | 5.18%  |

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Table 4. Within Lot precision on UNICAP for IMP tube

|  No | Analyte/Unit | mean | SD | CV(%) | 95% LCL | 95% UCL  |
| --- | --- | --- | --- | --- | --- | --- |
|  38 | IgE(IU/ml) | 111.67 | 3.15 | 2.82% | 1.58% | 4.06%  |

Table 5. Between-Lot precision on ROCHE PPI for IMP tube

|  No | Analyte/Unit | mean | SD | CV(%) | 95% LCL | 95% UCL  |
| --- | --- | --- | --- | --- | --- | --- |
|  1 | ALT(U/L) | 19.92 | 0.67 | 3.36% | 1.89% | 4.83%  |
|  2 | AST(U/L) | 20.78 | 0.9 | 4.33% | 2.43% | 6.23%  |
|  3 | ALP(U/L) | 58.94 | 2.07 | 3.51% | 1.97% | 5.05%  |
|  4 | GGT(U/L) | 27.68 | 0.97 | 3.50% | 1.97% | 5.03%  |
|  5 | TP(g/L) | 66.39 | 0.75 | 1.13% | 0.63% | 1.63%  |
|  6 | ALB(g/L) | 39.08 | 1 | 2.56% | 1.44% | 3.68%  |
|  7 | TBIL(umol/L) | 11.46 | 0.41 | 3.58% | 2.01% | 5.15%  |
|  8 | DBIL(umol/L) | 6.28 | 0.2 | 3.18% | 1.79% | 4.57%  |
|  9 | BUN(mmol/L) | 4.45 | 0.18 | 4.04% | 2.27% | 5.81%  |
|  10 | CREAT(umol/L) | 69.65 | 3.32 | 4.77% | 2.68% | 6.86%  |
|  11 | UA(umol/L) | 276.35 | 10.14 | 3.67% | 2.06% | 5.28%  |
|  12 | GLU(mmol/L) | 4.92 | 0.17 | 3.46% | 1.94% | 4.98%  |
|  13 | CHOL(mmol/L) | 4.55 | 0.2 | 4.40% | 2.47% | 6.33%  |
|  14 | TG(mmol/L) | 0.83 | 0.03 | 3.61% | 2.03% | 5.19%  |
|  15 | Apo-A1(g/L) | 1.22 | 0.03 | 2.46% | 1.38% | 3.54%  |
|  16 | Apo-B(g/L) | 0.76 | 0.02 | 2.63% | 1.48% | 3.78%  |
|  17 | K(mmol/L) | 3.96 | 0.14 | 3.54% | 1.99% | 5.09%  |
|  18 | Na(mmol/L) | 137.49 | 0.94 | 0.68% | 0.38% | 0.98%  |
|  19 | Cl(mmol/L) | 100.96 | 1.07 | 1.06% | 0.60% | 1.52%  |
|  20 | Ca(mmol/L) | 2.23 | 0.04 | 1.79% | 1.01% | 2.57%  |
|  21 | P(mmol/L) | 1.09 | 0.03 | 2.75% | 1.54% | 3.96%  |
|  22 | Mg(mmol/L) | 0.89 | 0.03 | 3.37% | 1.89% | 4.85%  |
|  23 | CK(U/L) | 72.92 | 1.96 | 2.69% | 1.51% | 3.87%  |
|  24 | CK-MB(U/L) | 14.35 | 0.65 | 4.53% | 2.54% | 6.52%  |
|  25 | CRP(mg/L) | 3.44 | 0.17 | 4.94% | 2.77% | 7.11%  |
|  26 | IgG(g/L) | 11.58 | 0.4 | 3.45% | 1.94% | 4.96%  |
|  27 | IgA(g/L) | 2.22 | 0.08 | 3.60% | 2.02% | 5.18%  |
|  28 | IgM(g/L) | 1.06 | 0.05 | 4.72% | 2.65% | 6.79%  |
|  29 | C3(g/L) | 1.04 | 0.05 | 4.81% | 2.70% | 6.92%  |
|  30 | C4(g/L) | 0.3 | 0.01 | 3.33% | 1.87% | 4.79%  |
|  31 | RF(IU/ml) | 3.73 | 0.29 | 7% | 3.93% | 9.98%  |

Table 6. Between-Lot precision on Abbott i2000 for IMP tube

|  No | Analyte/Unit | mean | SD | CV(%) | 95% LCL | 95% UCL  |
| --- | --- | --- | --- | --- | --- | --- |
|  32 | Free T4(pmol/L) | 12.41 | 0.51 | 4.11% | 2.31% | 5.91%  |
|  33 | TSH(uIU/ml) | 2.94 | 0.06 | 2.04% | 1.15% | 2.93%  |

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Table 7. Between-Lot precision on Abbott Axsym for IMP tube

|  No | Analyte/Unit | mean | SD | CV(%) | 95% LCL | 95% UCL  |
| --- | --- | --- | --- | --- | --- | --- |
|  37 | cTnI(ng/ml) | 0.25 | 0.01 | 4% | 2.25% | 5.75%  |

Table 8. Between-Lot precision on UNICAP for IMPROVACUTER® Gel &amp; Clot Activator Tube

|  No | Analyte/Unit | mean | SD | CV(%) | 95% LCL | 95% UCL  |
| --- | --- | --- | --- | --- | --- | --- |
|  38 | IgE(IU/ml) | 106.68 | 2.88 | 2.70% | 1.52% | 3.88%  |

Results of the predicate type tube, BD SST, were very similar to the candidate tube type.

b. Linearity/assay reportable range:

Not applicable.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Real time shelf life studies of the IMP tubes showed that the tube is stable for 12 months when stored at  $4^{\circ}$  to  $25^{\circ}\mathrm{C}$ . The sponsor's acceptance criteria and protocol was provided and found to be acceptable.

To demonstrate analyte stability in the IMP tubes, analyte stability studies were performed at 0 hrs (as control), 24 hrs, 48 hrs after collecting blood into the tubes and stored at  $2 - 8^{\circ}\mathrm{C}$  and at  $22 - 25^{\circ}\mathrm{C}$  (in the original blood tubes). Studies were performed in conjunctions with the method comparison studies with 40 subjects. See summary in M.2.a. below.

The results of the study support the sponsor's claimed that the IMP tubes have analyte stability for up to 24 hours when stored at  $2 - 8^{\circ}\mathrm{C}$  and at  $22 - 25^{\circ}\mathrm{C}$  except for TBIL.

Additional stability study was performed to evaluate the stability of TBIL and the results provided by the sponsor demonstrated that TBIL is stable up to 20 hours when stored at  $22 - 25^{\circ}\mathrm{C}$ . This information is provided in the sponsor's package insert. Acceptance criteria for analyte stability was provided and found to be acceptable.

d. Detection limit:

Not applicable.

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e. Analytical specificity:

Not applicable.

f. Assay cut-off:

Not applicable.

# 2. Comparison studies:

# a. Method comparison with predicate device:

To demonstrate comparable performance with the predicate device, apparently healthy subjects and patients admitted into hospitals with various diseases were used. Testing was performed at two hospital sites. All subjects in the comparative studies have blood samples collected into the IMP tubes (candidate device) and the BD SST (predicate tubes) at the same time. The specimens were allowed to clot, and the serum was removed for testing immediately after centrifugation according to the instructions provided in the labeling. Evaluations were performed on a selective common chemistry analytes, immunology analytes, and serological analytes on multiple instrument platforms. A total of 41 analytes were evaluated and demonstrated comparable results between the IMP tubes and the BD SST tubes. Summary of the results (linear regressions correlations with  $95\%$  confidence intervals) on one representative platform with the analytes and instruments evaluated are provided in the tables below:

|  Analyte | Instrument(s) | Slope (95% CI) | Intercept (95% CI)  |
| --- | --- | --- | --- |
|  Total Protein | 1,2 | 0.9825 [0.9504,1.0146] | 1.2333 [-1.0015,3.4681]  |
|  Albumin | 1,2 | 0.9919 [0.9689,1.0149] | 0.3486 [-0.5711,1.2683]  |
|  Total Bilirubin | 1,2 | 0.9822 [0.9727,0.9917] | 0.2313 [0.04,0.4225]  |
|  Direct Bilirubin | 1,2 | 0.9957 [0.9894,1.002] | 0.019 [-0.0408,0.0787]  |
|  AST | 1,2 | 0.9977 [0.9913,1.0041] | -0.0575 [-0.4783,0.3632]  |
|  ALT | 1,2 | 1.0011 [0.9949,1.0073] | 0.1762 [0.2279,0.5803]  |
|  ALP | 1,2 | 1.0021 [0.9842,1.0201] | -0.9865[2.5229,0.5498]  |
|  GGT | 1,2 | 0.9983 [0.9927,1.004] | 0.1038 [-0.3709,0.5785]  |
|  Cholesterol | 1,2 | 0.9926 [0.9659,1.0194] | 0.0379 [-0.097,0.1729]  |
|  Potassium | 1,2 | 0.9668 [0.9104,1.0231] | 0.1074 [-0.1132,0.328]  |
|  Glucose | 1,2 | 0.9702 [0.9469,0.9935] | 0.1541 [0.0131,0.295]  |
|  Creatinine | 1,2 | 1.0064 [1.0016,1.0113] | 1.0737 [-0.1026,2.25]  |
|  Calcium | 1,2 | 1.0002 [0.963,1.0374] | 0.0066 [-0.076,0.0892]  |
|  Chloride | 1,2 | 0.9627 [0.8248,1.1006] | 3.8046 [-10.212,17.8211]  |
|  CK | 1,2 | 0.9999 [0.9981,1.0017] | -0.1745 [-1.4679,1.1268]  |
|  Magnesium | 1,2 | 0.9622 [0.9281,0.9963] | 0.0377 [0.0037,0.0717]  |
|  Phosphorous | 1,2 | 0.9676 [0.9359,0.9992] | 0.039 [-0.0006,0.0786]  |
|  Sodium | 1,2 | 0.9999 [0.9981,1.0017] | 0.0002 [-0.0006,0.0006]  |
|  Sodium | 1,2 | 1.0002 [0.963,1.0374] | 0.0002 [0.0006,0.0006]  |

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The slopes of the linear regression for all the analytes on all the platforms ranged from 0.9503 to 1.0155.

Concordance Table for anti-CMV IgG and IgM, anti-VZV-IgG (Qualitative tests)

|  Test | Agreement between IMP and BD tubes for positive results | Agreement between IMP and BD tubes for negative results  |
| --- | --- | --- |
|  CMV-IgG | 100% | 100%  |
|  CMV-IgM | 100% | 100%  |
|  VZV- IgG | 100% | 100%  |

# Instrument(s):

1: Roche Modular PPI
2: Beckman DXC 800
3: Abbott I2000

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4: Abbott AxSym
5: Beckman Access II
6: Roche E170
7: UNICAP Immuno CAP
8: Bayer Centaur
9: Anthos Microplate Reader
10: Bio-Tec Microplate Reader ELX800

Summary of all the method comparison studies:

Study 1: 127 adult subjects were recruited and tested in hospital site 1. Testing was performed in that hospital laboratory. Chemistry results were generated for 31 general chemistry analytes on a Roche PPI instrument and 5 immunoassay analytes on an Abbott I2000 instrument. Troponin I result was generated on an Abbott AxSym instrument and IgE result was generated on a UNICAP analyzer. Three serological analytes (CMV IgG, IgM and VZV-IgG) were generated on an Anthos micro-plate reader.

Study 2: 125 adult subjects were recruited and tested in hospital site 2. Testing was performed in that hospital laboratory. Chemistry results were generated for 31 general chemistry analytes on a Beckman DxC 800 instrument and 3 immunoassay analytes on a Bayer Centaur. Troponin I and hCG results were generated on a Beckman Access II instrument. Ferritin and IgE results were generated on a Roche E170 analyzer. Three serological analytes (CMV IgG, IgM and VZV-IgG) were generated on an ELX 800 micro-plate reader.

b. Matrix comparison:

Not applicable. These blood collection tubes are for serum only.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable

4. Clinical cut-off:

Not applicable

10

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5. Expected values/Reference range:

Not applicable

N. Proposed Labeling:

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

O. Conclusion:

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

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA/K093910](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKA/K093910)

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