STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW

K060968 · Wortham Laboratories, Inc. · GIZ · May 15, 2007 · Hematology

Device Facts

• Record ID: K060968
• Device Name: STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW
• Applicant: Wortham Laboratories, Inc.
• Product Code: GIZ · Hematology
• Decision Date: May 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

Wortham Laboratories Stasis 1 Coagulation Control (Normal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT, and Fibrinogen values in the normal range.

Device Story

Stasis 1 Coagulation Control is a liquid stable citrated plasma derived from healthy human donors, supplemented with stabilizers and buffers. It serves as a quality control material for clinical coagulation analyzers to monitor PT, APTT, and Fibrinogen assays. The device is intended for use by clinical laboratory professionals. By providing a standardized, stable control with known expected ranges, it allows laboratories to verify the accuracy and precision of their coagulation testing systems. This monitoring helps ensure reliable diagnostic results for patients undergoing coagulation studies, thereby supporting clinical decision-making regarding hemostasis and anticoagulant therapy.

Clinical Evidence

Bench testing only. Precision studies (n=180 per control) showed CVs < 1.6% for PT/APTT/Fibrinogen. Linearity studies confirmed reportable ranges for warfarin and heparin monitoring. Method comparison against predicates using 120 patient samples (normal, coumadin, heparinized, lupus anticoagulant) showed high correlation (r=0.844 to 0.999).

Technological Characteristics

Liquid stable citrated human plasma with added stabilizers and buffers. Storage: ≤ -2° C. Analyte factors: PT, APTT, Fibrinogen. No software or electronic components.

Indications for Use

Indicated for use as a quality control to monitor the performance of PT, APTT, and Fibrinogen assays in clinical laboratories, yielding values in the normal range.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Pacific Hemostasis Coagulation Control Level I (K984129)

Submission Summary (Full Text)

{0}------------------------------------------------

MAY 15 2007

### Premarket Notification 510 (k) Summary

### Stasis 1 Coagulation Control

The assigned 510K number is: K060968

| Applicant: | Wortham Laboratories, Inc.<br>6340 Bonny Oaks Dr<br>Chattanooga, TN 37416<br>Tel: [phone]<br>Fax: [phone] |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Stasis 1 Coagulation Control (Normal) |
| Common Name: | Normal Coagulation Control |
| Classification Name: | Plasma, Coagulation Control, a class II device as per 21 CFR section 864.5425<br>(Product Code GGC). This device is intended for clinical use<br>in conjunction with an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Coagulation Control Level I (K984129) |

#### Description

Wortham Laboratories Stasis 1 Coagulation Control (Normal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV.

#### Intended Use

Wortham Laboratories Stasis 1 Coagulation Control (Normal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yicld PT, APTT, and Fibrinogen values in the normal range.

#### Labeling

{1}------------------------------------------------

| Characteristics<br>Intended Use | New Device | Predicate |
|---------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|
| | Routine coagulation for PT, PTT, fibrinogen assays in the normal range | Routine coagulation for PT, PTT, fibrinogen assays in the normal range |
| Control<br>Composition | Liquid Human citrated plasma | Lypholyzed human citrated plasma |
| Stability | 12 months @≤ -2° C<br>30 days @ 2-4° С | 35 months @ 2-8° C, lypholyzed<br>8 hours @ 2-8° C, rehydrated |
| Reference<br>Values | CV% PT | CV% PT |
| | within-run (ISI=1.54) 0.75% | within-run (ISI=1.54) 0.90% |
| | within-run (ISI=1.20) 0.88% | within-run (ISI=1.20) 1.40% |
| | run-run (ISI=1.54) 0.67% | run-run (ISI=1.54) 0.85% |
| | run-run (ISI=1.20) 0.89% | run-run (ISI=1.20) 1.38% |
| | CV% APTT | CV% APTT |
| | within-run (Kaolin) 0.63% | within-run (Kaolin) 1.54% |
| | within-run (Ellagic-Acid) 0.62% | within-run (Ellagic-Acid) 0.85% |
| | run-run (Kaolin) 0.61% | run-run (Kaolin) 1.20% |
| | run-run (Ellagic Acid) 0.60% | run-run (Ellagic Acid) 0.85% |
| | CV% Fibrinogen | CV% Fibrinogen |
| | within-run 0.56% | within-run 0.59% |
| | run-run 0.57% | run-run 0.60% |
| Expected Range | Mechanical Mean ± 2SD | Mechanical Mean ± 2SD |
| | PT 11.67 11.5-11.8 sec | PT 11.66 11.4-11.9 sec |
| | APTT: 29.51 29.3-29.7 sec | APTT: 28.38 28.0-28.8 sec |
| | Fibrinogen: 306.3 301-313 g/dl | Fibrinogen: 306.3 297-315 g/dl |
| Storage | ≤ -2° C | 2 - 8° C |
| Assay Factors | PT, APTT, Fibrinogen | PT, APTT, Fibrinogen |

:

·

{2}------------------------------------------------

#### Conclusions

#### Stasis 1

Wortham Laboratories Stasis 1 and Pacific Hemostasis Coagulation Control Level I have the same intended use, as normal controls for the quantitative measurement of the (PT), Activated Partial Thromboplastin Time (APTT) and fibrinogen levels. Both are preparations of citrated plasma obtained from normal donors with added stabilizers and buffers.

Mechanical assays of Stasis 1 to the predicate normal plasma control with two different sensitive thromboplastin reagents, with an ISI of 1.20 and 1.58, yielded a within-run standard deviation of 0.0809 and 0.0922 for Stasis 1 respectively, compared to a 0.1714 and a 0.1050 SD for the predicate control from the same reagents. A run-run precision of Stasis 1 produced a 0.1026 and 0.0784 SD with the two thromboplastin reagents, compared to 0.1733 and 0.0987 SD of Pacific Hemostasis Control.

Mechanical measurements of the APTT in both Stasis 1 and Pacific Hemostasis Level 1 Control with two different activator reagents, Kaolin and ellagic acid, produced a within-run 0.0863 and a 0.1792 standard deviation, respectively, while the predicate control vielded a 0.1989 and a 0.2455 SD. A run-run precision of the Stasis 1 Control measured at 0.1705 and 0.1749 SD to the two APTT activators, contrasted to Pacific Hemostasis Level I Controls 0.3339 and 0.2453 SD.

The processing of the Fibrinogen levels in both study graphs on the fibrometer instrument produced a within-run 0.0850 and a 0.0858 run-run standard deviation for Stasis 1, which a within-run 0.089 SD and run-run 0.0900 SD was observed in the Pacific Hemostasis Level 1 Control.

Reproducibility of the two controls yielded a 0.86% within-run coefficient of variation and a run-run 0.89% CV for Stasis 1, compared respectively to the predicate control of 1.36% CV.

The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Stasis 1 Coagulation Control to Pacific Hemostasis Coagulation Control Level I. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

{3}------------------------------------------------

K0609868

MAY 15 2007

## Premarket Notification 510 (k) Summary

### Stasis 2 Coagulation Control

The assigned 510K number is: K060968

| Applicant: | Wortham Laboratories, Inc.<br>6340 Bonny Oaks Dr<br>Chattanooga, TN 37416<br>Tel: [phone]<br>Fax: [phone] |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) |
| Common Name: | Abnormal Coagulation Control |
| Classification Name: | Plasma, Coagulation Control, a class II device as per 21 CFR section 864.5425<br>(Product Code GGC). This device is intended for clinical use<br>in conjunction with an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Coagulation Control Level II (K984130) |

#### Description

Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBSAg and negative for antibodies to HIV and HCV.

#### Intended Use

Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the moderate abnormal range.

#### Labeling

{4}------------------------------------------------

| Characteristics<br>Intended Use | New Device<br>Routine coagulation for PT, PTT, assays in the<br>moderately abnormal range | Predicate<br>Routine coagulation for PT, PTT, assays in<br>the moderately abnormal range | | | | | |
|---------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------|------------|-------|---------------|--|
| Control<br>Composition | Liquid Human citrated plasma | Lypholyzed human citrated plasma | | | | | |
| Stability | 12 months @ ≤ -2° C<br>30 days @ 2-4° C | 34 months @ 2-8° C, lypholyzed<br>8 hours @ 2-8° C, rehydrated | | | | | |
| Reference<br>Values | CV% | PT | CV% | PT | | | |
| | within-run (ISI=1.54) | 1.01% | within-run (ISI=1.54) | 1.41% | | | |
| | within-run (ISI=1.20) | 1.10% | within-run (ISI=1.20) | 1.28% | | | |
| | run-run (ISI=1.54) | 0.98% | run-run (ISI=1.54) | 1.30% | | | |
| | run-run (ISI=1.20) | 1.01% | run-run (ISI=1.20) | 1.19% | | | |
| | CV% | APTT | CV% | APTT | | | |
| | within-run (Kaolin) | 0.76% | within-run (Kaolin) | 1.00% | | | |
| | within-run (Ellagic-Acid) | 0.50% | within-run (Ellagic-Acid) | 0.91% | | | |
| | run-run (Kaolin) | 0.76% | run-run (Kaolin) | 1.06% | | | |
| | run-run (Ellagic Acid) | 0.48% | run-run (Ellagic Acid) | 0.90% | | | |
| Expected Range | Mechanical | Mean | + 2SD | Mechanical | Mean | + 2SD | |
| | PT | 20.14 | 19.9-20.3 sec | PT | 20.25 | 19.7-20.8 sec | |
| | APTT: | 55.75 | 54.9-56.6 sec | APTT: | 55.01 | 53.9-56.2 sec | |
| Storage | ≤ -2° C | | | 2 - 8° C | | | |
| Assay Factors | PT, APTT | | | PT, APTT | | | |

:

.

{5}------------------------------------------------

#### Conclusions

#### Stasis 2

Wortham Laboratories Stasis 2 and Pacific Hemostasis Coagulation Control Level II have the same intended use, as normal controls for the quantitative measurement of the Prothrombin Time (PT). Activated Partial Thromboolastin Time (APTT). Both are preparations of citrated plasma obtained from normal donors with added stabilizers and buffers.

Mechanical assays of Stasis 2 to the predicate moderately abnormal with two different sensitive thromboplastin reagents, 1.20 ISI and 1.58 ISI, yielded a standard deviation of 0.5992 and 0.2023 for Stasis 2 respectively, compared to a 0.2856 SD for the predicate control from the same reagents. A run-run precision of Stasis 2 produced a 0.3664 and 0.1984 SD with the two thromboplastin reagents, compared to 0.4296 and 0.2644 SD of Pacific Hemostasis Control.

Mcchanical measurements of the APTT in both Stasis 2 and Pacific Hemostasis Level II Control with two different activator reagents, Kaolin and ellagic acid, produced a 0.4135 and a 0.2341 standard deviation, respectively, while the predicate control yielded a 0.5721 and a 0.4045 SD. A run-run precision of the Stasis 2 Control measured at 0.41 36 and 0.2233 SD to the two APTT activators, contrasted to Pacific Hemostasis Level II Controls 0.5628 and 0.4043 SD.

Reproducibility of the two controls yielded a 1.10% within-run coefficient of variation and a run-run 1.01% CV for Stasis 2, compared respectively to the predicate control of 1.28% CV and 1.19% CV.

The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Stasis 2 Coagulation Control to Pacific Hemostasis Coagulation Control Level II. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

{6}------------------------------------------------

Koco968

MAY 15 2007

## Wortham Laboratories, Inc.

### Premarket Notification 510 (k) Summary

### Stasis 3 Coagulation Control

The assigned 510K number is: K060968

| Applicant: | Wortham Laboratories, Inc.<br>6340 Bonny Oaks Dr<br>Chattanooga, TN 37416<br>Tel: [phone]<br>Fax: [phone] |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) |
| Common Name: | Abnormal Coagulation Control |
| Classification Name: | Plasma, Coagulation Control, a class II device as per 21 CFR section 864.5425<br>(Product Code GGC). This device is intended for clinical use<br>in conjunction with an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Coagulation Control Level III (K984131) |

#### Description

Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV.

#### Intended Use

Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the strongly abnormal range.

#### Labeling

{7}------------------------------------------------

·

| Characteristics | New Device | Predicate | | | | | | |
|---------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|---------------------------|------------|-------|-------|---------------|--|
| Intended Use | Routine coagulation for PT, PTT, assays in the high abnormal range | Routine coagulation for PT, PTT, assays in the high abnormal range | | | | | | |
| Control Composition | Liquid Human citrated plasma | Lypholyzed human citrated plasma | | | | | | |
| Stability | 12 months @ ≤ -2° C<br>30 days @ 2-4° C | 35 months @ 2-8° C, lypholyzed<br>8 hours @ 2-8° C, rehydrated | | | | | | |
| Reference Values | CV% | PT | CV% | PT | | | | |
| | within-run (ISI=1.54) | 1.45% | within-run (ISI=1.54) | 1.68% | | | | |
| | within-run (ISI=1.20) | 1.36% | within-run (ISI=1.20) | 1.52% | | | | |
| | run-run (ISI=1.54) | 1.46% | run-run (ISI=1.54) | 1.70% | | | | |
| | run-run (ISI=1.20) | 1.44% | run-run (ISI=1.20) | 1.34% | | | | |
| | CV% | APTT | CV% | APTT | | | | |
| | within-run (Kaolin) | 0.80% | within-run (Kaolin) | 1.12% | | | | |
| | within-run (Ellagic-Acid) | 0.76% | within-run (Ellagic-Acid) | 1.12% | | | | |
| | run-run (Kaolin) | 0.75% | run-run (Kaolin) | 1.15% | | | | |
| | run-run (Ellagic Acid) | 0.75% | run-run (Ellagic Acid) | 1.11% | | | | |
| Expected Range | Mechanical | Mean | ± 2SD | Mechanical | Mean | ± 2SD | | |
| | PT | 32.50 | 32.0-33.0 sec | | PT | 32.49 | 31.4-33.6 sec | |
| | APTT: | 70.49 | 69.4-71.5 sec | | APTT: | 70.13 | 68.8-71.4 sec | |
| Storage | ≤ -2° C | 2 - 8° C | | | | | | |
| Assay Factors | PT, APTT | | | PT, APTT | | | | |

:

{8}------------------------------------------------

#### Conclusions

#### Stasis 3

Wortham Laboratories Stasis 3 and Pacific Hemostasis Coagulation Control Level III have the same intended use, as normal controls for the quantitative measurement of the Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). Both are preparations of citrated plasma obtained from normal donors with added stabilizers and buffers.

Mechanical assays of Stasis 3 to the predicate moderately abnormal plasma control with two different sensitive thromboplastin reagents, 1.20 ISI and 1.58 ISI, yielded a standard deviation of 0.8385 and 0.4721 for Stasis 3 respectively, compared to a 0.9333 and a 0.5467 for the predicate control from the same reagents. A run-run precision of Stasis 3 produced a 0.841 and 0.4712 SD with the two thromboplastin reagents, compared to 0.9696 and 0.5512 SD of Pacific Hemostasis Control.

Mechanical measurements of the APTT in both Stasis 3 and Pacific Hemostasis Level III Control with two different activator reagents, Kaolin and ellagic acid, produced a 0.5278 and a 0.4928 standard deviation, respectively, while the predicate control vielded a 0.7160 SD. A run-run precision of the Stasis 3 Control measured at 0.5273 and 0.4860 SD to the two APTT activators, contrasted to Pacific Hemostasis Level III Controls 0.8029 and 0.7133 SD.

Reproducibility of the two controls yielded a 1.35% within-run coefficient of variation and a run-run 1.36% CV for Stasis 3, compared respectively to the predicate control of 1.52% CV.

The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Stasis 3 Coagulation Control to Pacific Hemostasis Coagulation Control Level III. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

{9}------------------------------------------------

K060968

### Premarket Notification 510 (k) Summary

MAY 15 2007

### Serathan-B PT Reagent

The assigned 510K number is: K060968

| Applicant: | Wortham Laboratories, Inc.<br>6340 Bonny Oaks Dr<br>Chattanooga, TN 37416<br>Tel: [phone]<br>Fax: [phone] |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Serathan-B PT Reagent. |
| Common Name: | Prothrombin Time |
| Classification Name: | Prothrombin Time Test, is a class II device, as per 21 CFR 864.7750<br>(Product Code GJS). This device is intended for clinical use in conjunction with<br>an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Thromboplastin-D (K994100) |

#### Description

Wortham Laboratories Serathan-B PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium, stabilizer and buffer. Serathan-B is an in-vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays for Factors II, V. VII and X.

#### Intended Use

Wortham Laboratories Serathan-B PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-B is a moderately sensitive thromboplastin reagent.

#### Labeling

{10}------------------------------------------------

:

:

| Characteristics<br>Intended Use | New Device<br>Performance of Prothrombin Time (PT) testing<br>for the detection of coagulation abnormalities in<br>the extrinsic pathway | | | | Predicate<br>Performance of Prothrombin Time (PT) testing<br>for the detection of coagulation abnormalities in<br>the extrinsic pathway | | | | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------|------------|-------|-----------------------------------------------------------------------------------------------------------------------------------------|-------|------------|-------|-------|
| Reagent<br>Composition | Liquid Rabbit Thromboplastin | | | | Lypholyzed Rabbit Thromboplastin | | | | |
| Stability | 12 months @ ≤ -2° C<br>30 days @ 2-4° C | | | | 30 months @ 2-8° C, lypholyzed<br>7 days @ 2-8° C, rehydrated | | | | |
| Reference<br>Values | | | within-run | CV% | | | within-run | CV% | |
| | Level 1 | | | 0.80% | Level 1 | | | 0.90% | |
| | Level 2 | | | 1.27% | Level 2 | | | 1.41% | |
| | Level 3 | | | 1.42% | Level 3 | | | 1.68% | |
| | | | run-run | CV% | | | run-run | CV% | |
| | Level 1 | | | 1.75% | Level 1 | | | 0.85% | |
| | Level 2 | | | 1.22% | Level 2 | | | 1.30% | |
| | Level 3 | | | 1.44% | Level 3 | | | 1.70% | |
| | Lupus Sensitivity | | | CV% | Lupus Sensitivity | | | CV% | |
| | | | | 0.32% | | | | 1.67% | |
| | Factor Assay | | | CV% | Factor Assay | | | CV% | |
| | Factor II | | | 0.00% | Factor II | | | 0.39% | |
| | Factor V | | | 0.26% | Factor V | | | 0.32% | |
| | Factor VII | | | 0.19% | Factor VII | | | 0.32% | |
| | Factor X | | | 0.19% | Factor X | | | 0.31% | |
| Expected<br>Range | Mean (sec) | | | | Mean (sec) | | | | |
| | % | II | V | VII | X | II | V | VII | X |
| | 100 | 11.00 | 11.49 | 11.40 | 11.60 | 10.88 | 11.38 | 11.28 | 11.48 |
| | 50 | 11.01 | 11.89 | 12.41 | 11.39 | 10.88 | 11.80 | 12.32 | 13.13 |
| | 40 | 11.49 | 12.41 | 13.09 | 13.82 | 11.41 | 12.29 | 12.92 | 13.56 |
| | 30 | 11.79 | 13.19 | 13.90 | 14.91 | 11.70 | 13.00 | 13.71 | 14.73 |
| | 20 | 12.30 | 14.70 | 14.79 | 16.32 | 12.22 | 14.50 | 14.50 | 16.08 |
| | 10 | 13.71 | 17.12 | 16.48 | 20.02 | 13.63 | 16.93 | 16.17 | 19.81 |
| Linearity | 11.6 - 36.2 sec | | | | 11.1 - 35.6 sec | | | | |
| Storage | ≤ -2° C | | | | 2 - 8° C | | | | |
| Assay Factors | PT, Fibrinogen, Factors | | | | PT, Fibrinogen, Factors | | | | |

:

{11}------------------------------------------------

#### Conclusions

#### Serathan-B

Wortham Laboratories Serathan-B and Pacific Hemostasis Thromboplastin-D reagents have the same intended use, as for the quantitative measurement of the Prothrombin Time (PT), and Factors II, V, VII, X. Both reagents are preparations of rabbit thromboplastin and calcium chloride, with an International Sensitivity Index of 1.5 - 1.7.

All assays were measured on the fibrometer yielding a PT standard deviation of 0.0869, 0.2033 and 0.4721 for Scrathan-B on Level 1, Level 3, Level 3 plasma controls, respectively, compared to Pacific Hemostasis Thromboplastin-D of 0.1050, 0.2856, 0.5467 standard deviation on the same controls.

Comparing the precision of the two reagents in the factor assays produced a standard deviation of 0.03, 0.022 and 0.022 for Factors II, V, VII, X, respectively for Serathan-B, contrasted to 0.043, 0.036, and 0.036 for Thromboplastin-D.

Reproducibility of the two reagents yielded a 0.80% within-run coefficient of variation and a run-run 0.75% CV for Serathan-B, compared respectively to the predicate control of 0.91% CV and 0.89% CV.

The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Serathan-B to Pacific Hemostasis Thromboplastin-D. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

{12}------------------------------------------------

K0606768

### Premarket Notification 510 (k) Summary

### Serathan-A PT Reagent

MAY 15 2007

The assigned 510K number is: K060968

| Applicant: | Wortham Laboratories, Inc.<br>6340 Bonny Oaks Dr<br>Chattanooga, TN 37416<br>Tel: [phone]<br>Fax: [phone] |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Serathan-A PT Reagent. |
| Common Name: | Prothrombin Time |
| Classification Name: | Prothrombin Time Test, is a class II device, as per 21 CFR 864.7750<br>(Product Code GJS). This device is intended for clinical use in conjunction with<br>an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Thromboplastin-DS (K940082) |

#### Description

Wortham Laboratories Scrathan-A PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium, stabilizer and buffer. Serathan-A is an in-vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays for Factors II, V. VII and X.

#### Intended Use

Wortham Laboratories Serathan-A PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-A is a highly sensitive thromboplastin reagent.

#### Labeling

{13}------------------------------------------------

| Characteristics<br>Intended Use | New Device<br>Performance of Prothrombin Time (PT) testing<br>for the detection of coagulation abnormalities in<br>the extrinsic pathway | Predicate<br>Performance of Prothrombin Time (PT) testing<br>for the detection of coagulation abnormalities in<br>the extrinsic pathway |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Reagent<br>Composition | Liquid Rabbit Thromboplastin | Lypholyzed Rabbit Thromboplastin |
| Stability | 12 months @ ≤ -2° C<br>30 days @ 2-4° C | 30 months @ 2-8° C, lypholyzed<br>7 days @ 2-8° C, rehydrated |
| Reference<br>Values | within-run | |
| | | CV% |
| | Level 1 0.89%<br>Level 2 1.09%<br>Level 3 1.25% | Level 1 1.36%<br>Level 2 1.28%<br>Level 3 1.52% |
| | run-run | |
| | | CV% |
| | Level 1 0.88%<br>Level 2 1.08%<br>Level 3 1.28% | Level 1 1.38%<br>Level 2 1.19%<br>Level 3 1.58% |
| Lupus Sensitivity | | CV% |
| | 0.29% | 2.04% |
| | | CV% |
| | Factor Assay | Factor Assay |
| | Factor II 1.25%<br>Factor V 0.25%<br>Factor VII 0.25%<br>Factor X 0.18% | Factor II 0.42%<br>Factor V 0.37%<br>Factor VII 0.38%<br>Factor X 0.32% |
| Expected<br>Range | Mean (sec) | |
| | % II V VII X | % II V VII X |
| 100 | 11.79 11.79 11.99 11.90 | 11.69 11.67 11.90 11.80 |
| 50 | 11.80 13.41 12.79 13.11 | 11.72 13.31 12.70 12.98 |
| 40 | 12.02 14.20 12.98 13.60 | 11.92 14.09 12.92 13.51 |
| 30 | 12.38 15.20 13.82 14.52 | 12.30 15.13 13.72 14.38 |
| 20 | 12.99 16.29 14.11 15.21 | 12.80 16.22 14.02 15.10 |
| 10 | 14.31 18.66 15.51 17.52 | 14.02 18.48 15.38 17.30 |
| Linearity | 12.1 - 41.9 sec | 11.9 - 41.1 sec |
| Storage | ≤ -2° C | 2 - 8° C |
| Assay Factors | PT, Fibrinogen, Factors<br>II, V, VII, X | PT, Fibrinogen, Factors<br>II, V, VII, X |

.

ﺮ

{14}------------------------------------------------

#### Conclusions

#### Serathan-A

Wortham Laboratories Serathan-A and Pacific Hemostasis Thromboplastin-DS reagents have the same intended use, as for the quantitative measurement of the Prothrombin Time (PT), and Factors II, V, VII, X. Both reagents are preparations of rabbit thromboplastin and calcium chloride, with an International Sensitivity Index of 1.0 - 1.2.

All assays were measured on the fibrometer yiclding a PT standard deviation of 0.135, 0.3977 and 0.7746 for Serathan-A on Level 1, Level 2, Level 3 plasma controls, respectively, compared to Pacific Hemostasis Thromboplastin-DS of 0.1694, 0.4320, 0.8556 standard deviation on the same controls.

Comparing the precision of the two reagents in the factor assays produced a standard deviation of 0.030, 0.030, 0.030 and 0.022 for Factors II, V, VII, X, respectively for Serathan-A, contrasted to 0.0497, 0.043, and 0.038 for Thromboplastin-DS.

Reproducibility of the two reagents yielded a 1.09% within-run cocfficient of variation and a run-run 0.97% CV for Serathan-A, compared respectively to the predicate control of 1.18% CV.

The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Serathan-A to Pacific Hemostasis Thromboplastin-DS. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

{15}------------------------------------------------

1660968

MAY 15 2007

## Premarket Notification 510 (k) Summary

### Intrin-EA APTT Reagent

The assigned 510K number is: K060968

| Applicant: | Wortham Laboratories, Inc.<br>6340 Bonny Oaks Dr<br>Chattanooga, TN 37416<br>Tel: [phone]<br>Fax: [phone] |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Intrin-EA APTT Reagent. |
| Common Name: | Activated Partial Thromboplastin Time (APTT) |
| Classification Name: | Activated Partial Thromboplastin is a class II device, as per 21 CFR 864.7925<br>(Product Code GFO). This device is intended for clinical use in conjunction<br>with an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis APTT-LS (K891337) |

#### Description

Wortham Laboratories Intrin-EA APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic hemostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit cephalin with the surface activator ellagic acid.

#### Intended Use

Wortham Laboratories Intrin-EA APTT is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-EA reagent is sensitive to mild coagulopathies.

#### Labeling

{16}------------------------------------------------

| Substantial Equivalence<br>Characteristics | New Device | | Predicate | |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| Intended Use | Performance of Activated Partial<br>Thromboplastin Time (APTT) testing for the<br>detection of coagulation abnormalities in the<br>intrinsic pathway | | Performance of Activated Partial Thromboplastin<br>Time (APTT) testing for the detection of<br>coagulation abnormalities in the intrinsic pathway | |
| Reagent<br>Composition | Liquid Rabbit Thromboplastin with ellagic<br>acid activator | | Liquid Rabbit Thromboplastin with ellagic acid<br>activator | |
| Stability | 12 months @ ≤ -2° C<br>30 days @ 2-4° С | | 22 months @ 2-8° C, lypholyzed<br>30 days @ 2-8° C, rehydrated | |
| Reference<br>Values | within-run | CV% | within-run | CV% |
| | Level 1 | 0.51% | Level 1 | 0.85% |
| | Level 2 | 0.41% | Level 2 | 0.91% |
| | Level 3 | 0.73% | Level 3 | 1.12% |
| | run-run | CV% | run-run | CV% |
| | Level 1 | 0.51% | Level 1 | 0.85% |
| | Level 2 | 0.44% | Level 2 | 0.90% |
| | Level 3 | 0.71% | Level 3 | 1.11% |
| | Heparin Sensitivity | CV% | Heparin Sensitivity | CV% |
| | 0.25 U/ml | 0.71% | 0.25 U/ml | 1.03% |
| | 0.35 U/ml | 0.54% | 0.35 U/ml | 0.91% |
| | Lupus Sensitivity | CV% | Lupus Sensitivity | CV% |
| | | 4.39% | | 7.81% |
| | Factor Assay | CV% | Factor Assay | CV% |
| | Factor VIII | 0.17% | Factor VIII | 0.23% |
| | Factor IX | 0.17% | Factor IX | 0.24% |
| | Factor XI | 0.14% | Factor XI | 0.29% |
| | Factor XII | 0.13% | Factor XII | 0.26% |
| Expected<br>Range | Mean (sec) | | Mean (sec) | |
| % | VIII | IX | XI | XII |
| 100 | 29.36 | 28.54 | 29.47 | 26.82 |
| 50 | 33.86 | 32.38 | 34.74 | 29.89 |
| 40 | 35.08 | 34.03 | 36.26 | 31.14 |
| 30 | 37.33 | 36.34 | 38.61 | 32.23 |
| 20 | 40.47 | 38.64 | 41.35 | 33.33 |
| 10 | 45.10 | 40.89 | 46.84 | 35.04 |
| | 28.23 | 27.48 | 28.32 | 25.78 |
| | 32.57 | 31.26 | 33.36 | 28.65 |
| | 33.83 | 33.02 | 35.03 | 29.78 |
| | 36.13 | 35.12 | 37.30 | 31.09 |
| | 39.20 | 37.40 | 40.14 | 32.07 |
| | 43.78 | 39.86 | 45.70 | 33.21 |
| Linearity | 29.0 - 70.7 sec | | 28.5 - 69.6 sec | |
| Storage | < -2° C | | 2 - 8° C | |
| Assay Factors | APTT, Heparin, Factors | | APTT, Heparin, Factors | |

:

{17}------------------------------------------------

#### Conclusions

#### Intrin-EA

Wortham Laboratories Intrin-EA and Pacific Hemostasis APTT-LS reagents have the same intended use, as for the quantitative measurement of the Activated Partial Thromboplastin Time (APTT), Heparin, and Factors VIII, IX, XI, XII. Both reagents are preparations of rabbit thromboplastin and ellagic acid as an activator.

All assays were measured on the fibrometer yielding an APTT standard deviation of 0.1483, 0.1968 for Intrin-EA on Level 1, Level 3 plasma controls, respectively, compared to Pacific Hemostasis APTT-LS of 0.1908, 0.4030, 0.8900 standard deviation on the same controls.

Intrin-EA sensitivity to heparin at 0.25 U/ml, yielded a 0.2236 standard deviation to both levels of heparin compared to 0.3078 and 0.3664 standard deviation, respectively, in the predicate product.

Comparing the precision of the two reagents in the factor assays produced a standard deviation of 0.049, 0.048, 0.043, and 0.036 SD for Factors VIII, IX, XI, XII, respectively for Intrin-EA, to 0.064, 0.065, 0.083, and 0.068 SD for APTT-LS.

Reproducibility of the two reagents yielded a 0.71% cocfficient of variation at 0.25 U/ml and 0.54% CV at 0.35 U/ml heparin, compared to APTT-LS 1.03% CV and 0.91% CV, respectively.

The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial cquivalence claim for Wortham Laboratories Intrin-EA to Pacific Hemostasis APTT-LS. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

{18}------------------------------------------------

K060968

MAY 1 5 2007

### Premarket Notification 510 (k) Summary

### Intrin-SI APTT Reagent

The assigned 510K number is: K060968

| Applicant: | Wortham Laboratories, Inc.<br>6340 Bonny Oaks Dr<br>Chattanooga, TN 37416<br>Tel: [phone]<br>Fax: [phone] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Intrin-SI APTT Reagent is a liquid stable extract of<br>rabbit brain thromboplastin, containing stabilizers and buffers. Intrin-SI is an<br>in-vitro diagnostic reagent intended for use for the performance of a citrated<br>Partial Thromboplastin Time (APTT) testing and quantitative PTT-based factor<br>assays for Factors XII, XI, IX and VIII. |
| Common Name: | Activated Partial Thromboplastin Time (APTT) |
| Classification Name: | Activated Partial Thromboplastin is a class II device, as per 21 CFR 864.7925<br>(Product Code GFO). This device is intended for clinical use in conjunction<br>with an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Kontact (K023362) |

#### Description

Wortham Laboratories Intrin-SI APTT reagent is intended for use in determining activated partial thromboplasin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic hemostatic pathway requires coagulation factors XII, XI, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit cephalin with the surface activator Kaolin.

#### Intended Use

Wortham Laboratories Intrin-SI is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activat…