CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797

K091216 · Siemens Healthcare Diagnostics · JIL · Oct 9, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091216
• Device Name: CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIL · Clinical Chemistry
• Decision Date: Oct 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Indications for Use

The Clinitek Status®+ Urine Chemistry Analyzer is a portable analyzer. It is designed to read only Siemens Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following in urine: Albumin, Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG). These measurements are used to assist diagnosis in the following areas: - Kidney Function - Urinary tract infections - Metabolic disorders (e.g. diabetes mellitus) - Liver Function - Pregnancy Tests performed using the Clinitek Status®+ Analyzer are intended for in vitro diagnostic use only. The Clinitek Status®+ Analyzer is intended for near patient (point-of-care) facilities and centralized laboratory locations.

Device Story

Portable urine chemistry analyzer; reads Siemens Reagent Strips and Clinitest hCG tests. Optical system uses six LEDs, light guide, mirror, lens, and detector to measure reflected light from test strips/cassettes. Microprocessor converts light intensity into clinical results. Features include automatic strip identification, humidity-exposure quality check, user-selectable reporting, and access restrictions. Connect System variant adds barcode entry, QC management, and network connectivity. Used in point-of-care and lab settings by healthcare professionals. Provides objective, automated analysis to assist clinical diagnosis of metabolic, renal, and hepatic conditions, and pregnancy.

Clinical Evidence

Internal performance study evaluated 150 urine specimens comparing the modified device (Clinitek Status+) against the predicate (Clinitek Status). Testing covered urinalysis strips (Multistix 10SG) and hCG cassettes. Results demonstrated percent positive agreement (relative sensitivity) and percent negative agreement (relative specificity) met prescribed requirements. Software verification and validation plans, including risk management, were provided.

Technological Characteristics

Reflectance photometer; six LEDs, light guide, mirror, lens, detector. Portable form factor. Connectivity: optional LIS/HIS via network module. Software: embedded firmware for instrument control and data processing. Calibration: automated via white reflectance bar on test strip table. Sterilization: N/A (in vitro diagnostic instrument).

Indications for Use

Indicated for use in near-patient (point-of-care) and centralized laboratory settings to measure urine analytes (Albumin, Bilirubin, Blood, Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein/Creatinine ratio, Albumin/Creatinine ratio, Specific Gravity, Urobilinogen, and hCG) to assist in diagnosing kidney function, urinary tract infections, metabolic disorders (e.g., diabetes), liver function, and pregnancy.

Regulatory Classification

Identification

A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

Predicate Devices

• Clinitek Status Urine Chemistry Analyzer (K031947)
• Clinitek Status Urine Chemistry Analyzer (K032563)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k091216

B. Purpose for Submission:
New 510(k) to modify the Multistix® 10SG urine test strip and to modify the Clinitek urinalysis instrument software to read the IR banded test strip which contains an identification pad specifically for the Siemens Multistix 10SG urine test strip.

C. Measurand:
Glucose, Blood (Occult), human Chorionic Gonadotropin (hCG), Creatinine, Albumin, Protein, Bilirubin, Ketone, Leukocytes, Nitrite, pH, Specific Gravity, and Urobilinogen.

D. Type of Test:
Semi-quantitative and Qualitative immunochromatographic

E. Applicant:
Siemens Healthcare Diagnostics

F. Proprietary and Established Names:
Clinitek Status+Analyzer and Clinitek Status Connect System

G. Regulatory Information:

1. Regulation section:
21CFR §862.1340-Urinary glucose (nonquantitative) test system.
21 CFR §864.6550-Occult blood test.
21 CFR §862.1155- Human chorionic gonadotropin (HCG) test system.
21CFR §862.1225 -Creatinine test system.
21 CFR §862.1645-Urinary protein or albumin (nonquantitative) test system
21 CFR §862.1115-Urinary bilirubin and its conjugates (nonquantitative) test system.
21 CFR §862.1435-Ketones (nonquantitative) test system.
21 CFR §864.7675-Leukocyte peroxidase test.
21 CFR §862.1510-Nitrite (nonquantitative) test system.
21 CFR §862.1550-Urinary pH (nonquantitative) test system.
21 CFR §862.2800 Refractometer for clinical use.
21 CFR §862.1785-Urinary urobilinogen (nonquantitative) test system.
21CFR §862.2900 -Automated urinalysis system.

2. Classification:
Class II and I

3. Product code:
JIL - method, enzymatic, glucose (urinary, non-quantitative)
JIP-blood, occult, enzymatic method, in urine
JHI- radioimmunoassay, human chorionic gonadotropin
JFY-enzymatic method, creatinine
JIR-indicator method, protein or albumin (urinary, non-quant.)
JJB-azo-dyes, colorimetric, bilirubin & its conjugates (urinary, non-quant.)
JIN-nitroprusside, ketones (urinary, non-quant.)
LJX-test, urine leukocyte

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JMT-diazo (colorimetric), nitrite (urinary, non-quant)
CEN-dye-indicator, ph (urinary, non-quant.)
JRE-refractometer for clinical use
CDM- diazonium colorimetry, urobilinogen (urinary, non-quant.)
KQO- automated urinalysis system

4. Panel:
75 (Clinical Chemistry)

H. Intended Use:

1. Intended use(s):
See indication(s) for use below

2. Indication(s) for use:
The Clinitek Status®+ Urine Chemistry Analyzer is a portable analyzer. It is designed to read only Siemens Reagent Strips for Urinalysis and Clinitest® hCG tests.

This analyzer is intended for the measurement of the following in urine: Albumin, Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).

These measurements are used to assist diagnosis in the following areas:
- Kidney Function
- Urinary tract infections
- Metabolic disorders (e.g. diabetes mellitus)
- Liver Function
- Pregnancy

Tests performed using the Clinitek Status®+ Analyzer are intended for in vitro diagnostic use only.

The Clinitek Status®+ Analyzer is intended for near patient (point-of-care) facilities and centralized laboratory locations.

3. Special conditions for use statement(s):
Prescription use

4. Special instrument requirements:
Clinitek Status+Analyzer or Clinitek Status Connect System

I. Device Description:
The Clinitek Status®+ Analyzer, a device modification/enhancement to the current Clinitek Status®, is a portable analyzer. It is designed to read only Siemens Reagent Strips for Urinalysis and Clinitest® hCG tests.

Identical to the Clinitek Status Analyzer, the Clinitek Status+ analyzer is intended for

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the measurement of the following in urine: Albumin, Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG). There are no changes in reporting ranges as a result of this design improvement.

As with the current analyzer, the Clinitek Status®+ is intended for use in a physician's office or hospital laboratory. Tests performed using the Clinitek Status®+ analyzer are intended for in vitro diagnostic use.

The Clinitek Status®+ analyzer optical system, urinalysis strip analytical method, immunoassay cassette analytical method, and main test steps remain the same as Clinitek Status®. They are not impacted by this design upgrade.

Since the SPlus and SConnect (SPlus instrument with LIS connection) are instrument upgrades only, the reagents used on SPlus and SConnect are the same as the existing reagents used on the Status (predicate instrument). No changes were made to the reagents used with the Clinitek Status, nor were changes made to the instruments optics, reagent handling system, control system, or assay timing.

## J. Substantial Equivalence Information:

1. Predicate device name(s): Clinitek Status Urine Chemistry Analyzer
2. Predicate 510(k) number(s): k031947 and k032563
3. Comparison with predicate:

| | Device | Predicate |
| --- | --- | --- |
| Item | Clinitek Status®+ Analyzer
Clinitek Status® Connect System | Clinitek Status®
K031947
K032563 |
| Intended Use | Urine Chemistry Analyzer designed to read only Siemens Reagent Strips for Urinalysis and Clinitest® hCG tests.
This analyzer is intended for the measurement of the following in urine: Albumin, Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG). | Same |
| Instrument Optical System | Reflectance photometer consisting of six light emitting diodes, a light guide, a mirror, a lens and a detector. Light travels onto a lens where it is focused onto the detector, and the intensity is converted into electrical impulses to generate | Same |

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| | Device | Predicate |
| --- | --- | --- |
| Item | Clinitek Status®+ Analyzer
Clinitek Status® Connect System | Clinitek Status®
K031947
K032563 |
| | results. | |
| Urinalysis Strips
Analytical
Method | Light is reflected at specific wavelengths from the strip test pad “read area”. Reported results depend upon the degree of color change in the pad which is directly related to the concentration of the analyte in the urine. | Same |
| Immunoassay
Cassette
Analytical
Method | The cassette “read area” is scanned by detector at two wavelengths. The test and references readings are then used to determine presence or absence of hCG in the urine sample. | Same |
| Specimen Type | Urine | Same |
| Calibration
Method | Each time a test is run, the analyzer calibrates using a white calibration bar located at the back of the test strip table. | Same |
| Reported Output | Albumin, Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG). | Same |
| Main Strip Test
Steps
(Quick Test) | Select Strip Test from menu.
Select Start.
Dip strip in urine sample.
Place strip on system table.
Results Display. | Same |
| Main Cassette
Test Steps | Select Cassette Test from menu.
Select Start.
Draw urine into pipette then add into sample well.
Place cassette on system table.
Results Display. | Same |
| Automatic strip
identification | This functionality is extended to additional reagent strips where the strip type is automatically identified. | Limited to reagent strips with color band |
| Quality Check | Conducts a quality check to assess if the strip has been exposed to high humidity. | None |
| Reporting
Flexibility
(Optional) | Allows user to select specific test parameters to report from on a given strip. | None |
| Barcode
capability
(Optional) | Barcode data entry (operator ID, specimen ID, patient ID, medical records number, etc.) | None |
| Quality Control
Management
(Optional) | Enhanced QC compliance through QC prompts, scheduling and remote triggering, QC lockout, QC results recall, etc. | Limited to labeling recommendations |
| Operator
Management | Enhanced security via Authorized Operator ID: user/operator access restrictions | Limited to entry of Operator ID |

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| | Device | Predicate |
| --- | --- | --- |
| Item | Clinitek Status®+ Analyzer
Clinitek Status® Connect System | Clinitek Status®
K031947
K032563 |
| (Optional) | | |
| Connectivity
(Optional) | Clinitek Status connector is an optional module that enables hospital network (such as HIS/LIS) connectivity. This also allows copying a selected setup across multiple instruments via the network. | None |
| Data Storage | Patient and QC data storage: Clinitek Status+ analyzers may contain up to 950 patient test results, 200 QC test results, and up to 700 authorized operators | Limited to 200 test results |

K. Standard/Guidance Document Referenced (if applicable):
None referenced

L. Test Principle:
The test principles of the methods used on this device are in the Multistix urine test strips were cleared under k905396, k960546, k992257 and the Clinitest hCG test strip were cleared under k023944.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Subject of Clinitek Status Urine Chemistry Analyzer clearances k031947 and k032563
b. Linearity/assay reportable range:
Subject of Clinitek Status Urine Chemistry Analyzer clearances k031947 and k032563
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Subject of Clinitek Status Urine Chemistry Analyzer clearances k031947 and k032563, k905396, k960546, k992257 and k023944
d. Detection limit:
Subject of Clinitek Status Urine Chemistry Analyzer clearances k031947 and k032563
e. Analytical specificity:
Subject of Clinitek Status Urine Chemistry Analyzer clearances k031947 and k032563
f. Assay cut-off:
Subject of Clinitek Status Urine Chemistry Analyzer clearances k031947 and k032563

2. Comparison studies:
a. Method comparison with predicate device:
Different configurations of the new test system, as shown in the table below, were compared to the predicate device using over 500 urine samples (both native and spiked) for each urine test strip parameter.

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| Model | Test Strip | Combo Designation |
| --- | --- | --- |
| Status | No IR Bands | Predicate Device (Status-non-IR) |
| Status | IR Banded | Status-IR |
| Status Connect (SConnect) | No IR Bands | SConnect-non-IR |
| Status Connect (SConnect) | IR Banded | SConnect-IR |
| Status Plus (SPlus) | No IR Bands | SPlus-non-IR |
| Status Plus (SPlus) | IR Banded | SPlus-IR |

Color Block Agreement Summaries by analyte / Test condition

- Cases where test device gives same color block response as the predicate device are highlighted in yellow.
- Cases where color block response for the test device and predicate device differ by $\pm 1$ color block are highlighted in blue.
- For each cell in the tabular summary the exact % agreement (test/predicate*100) between the test and predicate device is shown in percent form below as the frequency for each analyte/color block.

% Exact Agreement = sum of specimens where color block response for the test device agrees exactly with the color block response for the predicate device divided by the total number of specimens (x100).

% Within One Block Agreement = (sum of cases where color block response for the test device agrees exactly with the color block response for the predicate device) + (the sum of the cases where the color block response for the test condition are $\pm 1$ color block relative the predicate condition) divided by the total number of specimens (x100).

Bilirubin Summary

| Test | Test Method | n | % Exact Agreement | % Within One Block |
| --- | --- | --- | --- | --- |
| Bilirubin | SConnect-IR | 543 | 95.0 | 100.0 |
| | SPlus-IR | 545 | 95.8 | 100.0 |

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Analyte: Bilirubin Test Condition: SConnect-IR

| Color Block Test | Color Block Predicate | | | | Total |
| --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | |
| 1 | 368
99.46 | 2
2.90 | 0
0.00 | 0
0.00 | 370 |
| 2 | 2
0.54 | 61
88.41 | 4
5.56 | 0
0.00 | 67 |
| 3 | 0
0.00 | 6
8.70 | 64
88.89 | 9
28.13 | 79 |
| 4 | 0
0.00 | 0
0.00 | 4
5.56 | 23
71.88 | 27 |
| Total | 370 | 69 | 72 | 32 | 543 |

$$
(368 + 61 + 64 + 23) = 516
$$

$$
(516 + 2 + 2 + 4 + 6 + 9 + 4) = 543
$$

$$
516 / 543 = 0.95
$$

$$
543 / 543 = 1.00
$$

Analyte: Bilirubin Test Condition: SPlus-IR

| Color Block Test | Color Block Predicate | | | | Total |
| --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | |
| 1 | 368
98.66 | 1
1.47 | 0
0.00 | 0
0.00 | 369 |
| 2 | 5
1.34 | 63
92.65 | 1
1.39 | 0
0.00 | 69 |
| 3 | 0
0.00 | 4
5.88 | 66
91.67 | 7
21.88 | 77 |
| 4 | 0
0.00 | 0
0.00 | 5
6.94 | 25
78.13 | 30 |
| Total | 373 | 68 | 72 | 32 | 545 |

Blood Summary

| Test | Test Method | n | % Exact Agreement | % Within One Block |
| --- | --- | --- | --- | --- |
| Blood | SConnect-IR | 543 | 92.8 | 100.0 |
| | SPlus-IR | 545 | 91.6 | 100.0 |

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Analyte: Blood
Test Condition: SConnect-IR

| Color Block Test | Color Block Predicate | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | 5 | |
| 1 | 225 | 8 | 0 | 0 | 0 | 233 |
| | 98.68 | 8.79 | 0.00 | 0.00 | 0.00 | |
| 2 | 3 | 75 | 3 | 0 | 0 | 81 |
| | 1.32 | 82.42 | 3.80 | 0.00 | 0.00 | |
| 3 | 0 | 8 | 71 | 6 | 0 | 85 |
| | 0.00 | 8.79 | 89.87 | 8.57 | 0.00 | |
| 4 | 0 | 0 | 5 | 63 | 5 | 73 |
| | 0.00 | 0.00 | 6.33 | 90.00 | 6.67 | |
| 5 | 0 | 0 | 0 | 1 | 70 | 71 |
| | 0.00 | 0.00 | 0.00 | 1.43 | 93.33 | |
| Total | 228 | 91 | 79 | 70 | 75 | 543 |

Analyte: Blood
Test Condition: SPlus-IR

| Color Block Test | Color Block Predicate | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | 5 | |
| 1 | 221 | 7 | 0 | 0 | 0 | 228 |
| | 96.51 | 7.53 | 0.00 | 0.00 | 0.00 | |
| 2 | 8 | 80 | 4 | 0 | 0 | 92 |
| | 3.49 | 86.02 | 5.06 | 0.00 | 0.00 | |
| 3 | 0 | 6 | 65 | 4 | 0 | 75 |
| | 0.00 | 6.45 | 82.28 | 5.71 | 0.00 | |
| 4 | 0 | 0 | 10 | 62 | 3 | 75 |
| | 0.00 | 0.00 | 12.66 | 88.57 | 4.05 | |
| 5 | 0 | 0 | 0 | 4 | 71 | 75 |
| | 0.00 | 0.00 | 0.00 | 5.71 | 95.95 | |
| Total | 229 | 93 | 79 | 70 | 74 | 545 |

Glucose Summary

| Test | Test Method | n | % Exact Agreement | % Within One Block |
| --- | --- | --- | --- | --- |
| Glucose | SConnect-IR | 543 | 89.3 | 99.8 |
| | SPlus-IR | 545 | 86.8 | 99.8 |

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Analyte: Glucose
Test Condition: SConnect-IR

| Color Block Test | Color Block Predicate | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | 5 | |
| 1 | 159
98.76 | 8
7.34 | 0
0.00 | 0
0.00 | 0
0.00 | 167 |
| 2 | 1
0.62 | 97
88.99 | 0
0.00 | 0
0.00 | 0
0.00 | 98 |
| 3 | 1
0.62 | 4
3.67 | 72
94.74 | 1
0.79 | 0
0.00 | 78 |
| 4 | 0
0.00 | 0
0.00 | 4
5.26 | 109
86.51 | 23
32.39 | 136 |
| 5 | 0
0.00 | 0
0.00 | 0
0.00 | 16
12.70 | 48
67.61 | 64 |
| Total | 161 | 109 | 76 | 126 | 71 | 543 |

Analyte: Glucose
Test Condition: SPlus-IR

| Color Block Test | Color Block Predicate | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | 5 | |
| 1 | 153
95.63 | 6
5.36 | 0
0.00 | 0
0.00 | 0
0.00 | 159 |
| 2 | 6
3.75 | 103
91.96 | 0
0.00 | 0
0.00 | 0
0.00 | 109 |
| 3 | 1
0.63 | 3
2.68 | 72
94.74 | 3
2.38 | 0
0.00 | 79 |
| 4 | 0
0.00 | 0
0.00 | 4
5.26 | 112
88.89 | 38
53.52 | 154 |
| 5 | 0
0.00 | 0
0.00 | 0
0.00 | 11
8.73 | 33
46.48 | 44 |
| Total | 160 | 112 | 76 | 126 | 71 | 545 |

Ketone Summary

| Test | Test Method | n | % Exact Agreement | % Within One Block |
| --- | --- | --- | --- | --- |
| Ketone | SConnect-IR | 543 | 82.7 | 99.6 |
| | SPlus-IR | 545 | 83.3 | 99.4 |

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Analyte: Ketone
Test Condition: SConnect-IR

| Color Block Test | Color Block Predicate | | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | 5 | 6 | |
| 1 | 199
97.55 | 8
24.24 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 207 |
| 2 | 5
2.45 | 21
63.64 | 17
14.91 | 0
0.00 | 0
0.00 | 0
0.00 | 43 |
| 3 | 0
0.00 | 4
12.12 | 95
83.33 | 8
10.81 | 0
0.00 | 0
0.00 | 107 |
| 4 | 0
0.00 | 0
0.00 | 2
1.75 | 64
86.49 | 8
19.05 | 2
2.63 | 76 |
| 5 | 0
0.00 | 0
0.00 | 0
0.00 | 2
2.70 | 25
59.52 | 29
38.16 | 56 |
| 6 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 9
21.43 | 45
59.21 | 54 |
| Total | 204 | 33 | 114 | 74 | 42 | 76 | 543 |

Analyte: Ketone
Test Condition: SPlus-IR

| Color Block Test | Color Block Predicate | | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | 5 | 6 | |
| 1 | 202
98.54 | 9
27.27 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 211 |
| 2 | 3
1.46 | 20
60.61 | 14
12.17 | 0
0.00 | 0
0.00 | 0
0.00 | 37 |
| 3 | 0
0.00 | 4
12.12 | 97
84.35 | 6
8.11 | 0
0.00 | 0
0.00 | 107 |
| 4 | 0
0.00 | 0
0.00 | 4
3.48 | 63
85.14 | 11
26.19 | 1
1.32 | 79 |
| 5 | 0
0.00 | 0
0.00 | 0
0.00 | 3
4.05 | 22
52.38 | 25
32.89 | 50 |
| 6 | 0
0.00 | 0
0.00 | 0
0.00 | 2
2.70 | 9
21.43 | 50
65.79 | 61 |
| Total | 205 | 33 | 115 | 74 | 42 | 76 | 545 |

Leukocytes Summary

| Test | Test Method | n | % Exact Agreement | % Within One Block |
| --- | --- | --- | --- | --- |
| Leukocyte | SConnect-IR | 543 | 91.9 | 99.6 |
| | SPlus-IR | 545 | 90.6 | 99.8 |

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Analyte: Leukocytes
Test Condition: SConnect-IR

| Color Block Test | Color Block Predicate | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | 5 | |
| 1 | 217
97.31 | 1
1.49 | 0
0.00 | 1
1.05 | 0
0.00 | 219 |
| 2 | 5
2.24 | 59
88.06 | 0
0.00 | 0
0.00 | 0
0.00 | 64 |
| 3 | 0
0.00 | 7
10.45 | 70
93.33 | 5
5.26 | 0
0.00 | 82 |
| 4 | 0
0.00 | 0
0.00 | 5
6.67 | 77
81.05 | 7
8.43 | 89 |
| 5 | 1
0.45 | 0
0.00 | 0
0.00 | 12
12.63 | 76
91.57 | 89 |
| Total | 223 | 67 | 75 | 95 | 83 | 543 |

Analyte: Leukocytes
Test Condition: SPlus-IR

| Color Block Test | Color Block Predicate | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | 5 | |
| 1 | 219
98.65 | 5
7.25 | 0
0.00 | 1
1.05 | 0
0.00 | 225 |
| 2 | 3
1.35 | 59
85.51 | 6
7.79 | 0
0.00 | 0
0.00 | 68 |
| 3 | 0
0.00 | 5
7.25 | 66
85.71 | 6
6.32 | 0
0.00 | 77 |
| 4 | 0
0.00 | 0
0.00 | 5
6.49 | 79
83.16 | 11
13.41 | 95 |
| 5 | 0
0.00 | 0
0.00 | 0
0.00 | 9
9.47 | 71
86.59 | 80 |
| Total | 222 | 69 | 77 | 95 | 82 | 545 |

Nitrite Summary

| Test | Test Method | n | % Exact Agreement | % Within One Block |
| --- | --- | --- | --- | --- |
| Nitrite | SConnect-IR | 543 | 99.1 | 100.0 |
| | SPlus-IR | 545 | 98.7 | 100.0 |

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Analyte: Nitrite
Test Condition: SConnect-IR

| Color Block Test | Color Block Predicate | | Total |
| --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | |
| 1 | 305
99.03 | 2
0.85 | 307 |
| 2 | 3
0.97 | 233
99.15 | 236 |
| Total | 308 | 235 | 543 |

Analyte: Nitrite
Test Condition: SPlus-IR

| Color Block Test | Color Block Predicate | | Total |
| --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | |
| 1 | 310
99.36 | 5
2.15 | 315 |
| 2 | 2
0.64 | 228
97.85 | 230 |
| Total | 312 | 233 | 545 |

Protein Summary

| Test | Test Method | n | % Exact Agreement | % Within One Block |
| --- | --- | --- | --- | --- |
| Protein | SConnect-IR | 543 | 87.3 | 99.8 |
| | SPlus-IR | 545 | 87.9 | 99.8 |

Analyte: Protein
Test Condition: SConnect-IR

| Color Block Test | Color Block Predicate | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | 5 | |
| 1 | 123
93.18 | 11
16.42 | 0
0.00 | 0
0.00 | 1
0.93 | 135 |
| 2 | 9
6.82 | 43
64.18 | 10
7.52 | 0
0.00 | 0
0.00 | 62 |
| 3 | 0
0.00 | 13
19.40 | 111
83.46 | 11
10.58 | 0
0.00 | 135 |
| 4 | 0
0.00 | 0
0.00 | 12
9.02 | 93
89.42 | 2
1.87 | 107 |
| 5 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 104
97.20 | 104 |
| Total | 132 | 67 | 133 | 104 | 107 | 543 |

{12}

Analyte: Protein
Test Condition: SPlus-IR

| Color Block Test | Color Block Predicate | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | 5 | |
| 1 | 124 | 10 | 0 | 0 | 1 | 135 |
| | 91.18 | 14.93 | 0.00 | 0.00 | 0.94 | |
| 2 | 12 | 46 | 4 | 0 | 0 | 62 |
| | 8.82 | 68.66 | 2.99 | 0.00 | 0.00 | |
| 3 | 0 | 33 | 114 | 7 | 0 | 132 |
| | 0.00 | 16.42 | 85.07 | 6.86 | 0.00 | |
| 4 | 0 | 0 | 16 | 95 | 5 | 116 |
| | 0.00 | 0.00 | 11.94 | 93.14 | 4.72 | |
| 5 | 0 | 0 | 0 | 0 | 100 | 100 |
| | 0.00 | 0.00 | 0.00 | 0.00 | 94.34 | |
| Total | 136 | 67 | 134 | 102 | 106 | 545 |

Specific Gravity Summary

| Test | Test Method | n | % Exact Agreement | % Within One Block |
| --- | --- | --- | --- | --- |
| Specific Gravity | SConnect-IR | 543 | 81.8 | 99.8 |
| | SPlus-IR | 545 | 82.6 | 100.0 |

Analyte: Specific Gravity
Test Condition: SConnect-IR

| Color Block Test | Color Block Predicate | | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | 5 | 6 | |
| 1 | 12 | 2 | 0 | 0 | 0 | 0 | 14 |
| | 92.31 | 2.94 | 0.00 | 0.00 | 0.00 | 0.00 | |
| 2 | 1 | 39 | 6 | 0 | 0 | 0 | 46 |
| | 7.69 | 57.35 | 2.69 | 0.00 | 0.00 | 0.00 | |
| 3 | 0 | 27 | 185 | 9 | 0 | 0 | 221 |
| | 0.00 | 39.71 | 82.96 | 5.45 | 0.00 | 0.00 | |
| 4 | 0 | 0 | 32 | 142 | 6 | 0 | 180 |
| | 0.00 | 0.00 | 14.35 | 86.06 | 9.52 | 0.00 | |
| 5 | 0 | 0 | 0 | 13 | 56 | 1 | 70 |
| | 0.00 | 0.00 | 0.00 | 7.88 | 88.89 | 9.09 | |
| 6 | 0 | 0 | 0 | 1 | 1 | 10 | 12 |
| | 0.00 | 0.00 | 0.00 | 0.61 | 1.59 | 90.91 | |
| Total | 13 | 68 | 223 | 165 | 63 | 11 | 543 |

{13}

Analyte: Specific Gravity
Test Condition: SPlus-IR

| Color Block Test | Color Block Predicate | | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | 5 | 6 | |
| 1 | 11
91.67 | 2
2.94 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 13 |
| 2 | 1
8.33 | 47
69.12 | 12
5.41 | 0
0.00 | 0
0.00 | 0
0.00 | 60 |
| 3 | 0
0.00 | 19
27.94 | 180
81.08 | 12
7.06 | 0
0.00 | 0
0.00 | 211 |
| 4 | 0
0.00 | 0
0.00 | 30
13.51 | 148
87.06 | 7
11.11 | 0
0.00 | 185 |
| 5 | 0
0.00 | 0
0.00 | 0
0.00 | 10
5.88 | 55
87.30 | 1
10.00 | 66 |
| 6 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 1
1.59 | 9
90.00 | 10 |
| Total | 12 | 68 | 222 | 170 | 63 | 10 | 545 |

Urobilinogen Summary

| Test | Test Method | n | % Exact Agreement | % Within One Block |
| --- | --- | --- | --- | --- |
| Urobilinogen | SConnect-IR | 535 | 95.7 | 100.0 |
| | SPlus-IR | 545 | 95.4 | 100.0 |

Analyte: Urobilinogen
Test Condition: SConnect-IR

| Color Block Test | Color Block Predicate | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | 5 | |
| 1 | 357
99.72 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 357 |
| 2 | 1
0.28 | 55
93.22 | 2
4.26 | 0
0.00 | 0
0.00 | 58 |
| 3 | 0
0.00 | 4
6.78 | 40
85.11 | 5
9.62 | 0
0.00 | 49 |
| 4 | 0
0.00 | 0
0.00 | 5
10.64 | 41
78.85 | 0
0.00 | 46 |
| 5 | 0
0.00 | 0
0.00 | 0
0.00 | 6
11.54 | 19
100.00 | 25 |
| Total | 358 | 59 | 47 | 52 | 19 | 535 |

{14}

Analyte: Urobilinogen
Test Condition: SPlus-IR

| Color Block Test | Color Block Predicate | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | 5 | |
| 1 | 367 | 0 | 0 | 0 | 0 | 367 |
| | 99.46 | 0.00 | 0.00 | 0.00 | 0.00 | |
| 2 | 2 | 54 | 2 | 0 | 0 | 58 |
| | 0.54 | 91.53 | 4.26 | 0.00 | 0.00 | |
| 3 | 0 | 5 | 40 | 5 | 0 | 50 |
| | 0.00 | 8.47 | 85.11 | 10.00 | 0.00 | |
| 4 | 0 | 0 | 5 | 39 | 0 | 44 |
| | 0.00 | 0.00 | 10.64 | 78.00 | 0.00 | |
| 5 | 0 | 0 | 0 | 6 | 20 | 26 |
| | 0.00 | 0.00 | 0.00 | 12.00 | 100.00 | |
| Total | 369 | 59 | 47 | 50 | 20 | 545 |

pH Summary

| Test | Test Method | n | % Exact Agreement | % Within One Block |
| --- | --- | --- | --- | --- |
| pH | SConnect-IR | 543 | 77.5 | 98.7 |
| | SPlus-IR | 545 | 81.1 | 97.8 |

{15}

Analyte: pH
Test Condition: SConnect-IR

| Color Block Test | Color Block Predicate | | | | | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | |
| 1 | 32
94.12 | 17
20.00 | 0
0.00 | 0
0.00 | 1
0.85 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 50 |
| 2 | 2
5.88 | 65
76.47 | 21
24.42 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 88 |
| 3 | 0
0.00 | 3
3.53 | 65
75.58 | 3
10.00 | 1
0.85 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 72 |
| 4 | 0
0.00 | 0
0.00 | 0
0.00 | 24
80.00 | 4
3.42 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 28 |
| 5 | 0
0.00 | 0
0.00 | 0
0.00 | 3
10.00 | 104
88.89 | 2
4.35 | 0
0.00 | 0
0.00 | 0
0.00 | 109 |
| 6 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 6
5.13 | 32
69.57 | 1
5.00 | 2
2.30 | 0
0.00 | 41 |
| 7 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 10
21.74 | 11
55.00 | 21
24.14 | 0
0.00 | 42 |
| 8 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 1
0.85 | 2
4.35 | 8
40.00 | 61
70.11 | 11
28.95 | 83 |
| 9 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 3
3.45 | 27
71.05 | 30 |
| Total | 34 | 85 | 86 | 30 | 117 | 46 | 20 | 87 | 38 | 543 |

Analyte: pH
Test Condition: SPlus-IR

| Color Block Test | Color Block Predicate | | | | | | | | | Total |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Frequency / Column % | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | |
| 1 | 28
84.85 | 11
12.36 | 0
0.00 | 0
0.00 | 1
0.85 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 40 |
| 2 | 5
15.15 | 68
76.40 | 11
12.79 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 84 |
| 3 | 0
0.00 | 10
11.24 | 74
86.05 | 2
6.67 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 86 |
| 4 | 0
0.00 | 0
0.00 | 1
1.16 | 23
76.67 | 2
1.71 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 26 |
| 5 | 0
0.00 | 0
0.00 | 0
0.00 | 5
16.67 | 108
92.31 | 2
4.35 | 0
0.00 | 0
0.00 | 0
0.00 | 115 |
| 6 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 5
4.27 | 32
69.57 | 8
42.11 | 5
5.75 | 1
2.63 | 51 |
| 7 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 8
17.39 | 2
10.53 | 7
8.05 | 0
0.00 | 17 |
| 8 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 1
0.85 | 4
8.70 | 9
47.37 | 71
81.61 | 1
2.63 | 86 |
| 9 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 0
0.00 | 4
4.60 | 36
94.74 | 40 |
| Total | 33 | 89 | 86 | 30 | 117 | 46 | 19 | 87 | 38 | 545 |

{16}

Clinitest hCG

An internal hCG study was conducted on 4 SConnect analyzers verifying the software changes did not impact the test results.

b. Matrix comparison:
Not Applicable

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

5. Expected values/Reference range:
Subject of Clinitek Status Urine Chemistry Analyzer clearances k031947 and k032563, k905396, k960546, k992257 and k023944

N. Instrument Name:
Clinitek Status+Analyzer and Clinitek Status Connect System

O. System Descriptions:
1. Modes of Operation:
Single sample application

2. Software:
FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No ☐

3. Specimen Identification:
Alpha-Numeric Keyboard optional Barcode reader

4. Specimen Sampling and Handling:

{17}

Test Strip, Test Cassette

5. Calibration:
Dark current, White reflectance strip

6. Quality Control:
The use of external quality control materials is recommended in the labeling.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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

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