HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM

• K Number: K110031
• Device Name: HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
• Manufacturer: INSTRUMENTATION LABORATORY CO.
• Date Cleared: 2011-08-24 ( 231 days)
• Product Code: GIR GGC
• Regulation Number: 864.8950

Intended Use

The HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays are qualitative in-vitro diagnostic products to aid in the detection of lupus anticoagulants in human citrated plasma by the diluted Russell's Viper Venom method, on the ACL TOP® Family. The HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays are intended to evaluate patients who have unexplained prolonged APTT test results The HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays should be used in parallel as an integrated test for Lupus Anticoagulant detection.

Device Description

DRVVT Screen and dRVVT Confirm are improved dRVVT reagents, intended to simplify and standardize the detection of Lupus Anticoagulant (LA) disorder in clinical chemistry evaluations. DRVVT Screen is poor in phospholipid, making it sensitive to LA. The additional amount of phospholipid in dRVVT Confirm neutralizes LA to give shorter clotting times. Russell's viper venom, in the presence of calcium, directly activates factor X (in a test sample). DRVVT Screen and dRVVT Confirm are therefore unaffected by contact factor abnormalities, factor VII, VIII and IX deficiencies, or inhibitors. As a result, dRVVT Screen and dRVVT Confirm are more specific tests for the evaluation of LA than APTT.

Predicate Devices

K990302

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in-vitro diagnostic assay based on chemical reactions and clotting times, with no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No
The device is an in-vitro diagnostic product used to aid in the detection of lupus anticoagulants; it is not for treatment purposes.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the assays are "qualitative in-vitro diagnostic products to aid in the detection of lupus anticoagulants." The "Device Description" also refers to simplifying and standardizing the detection of Lupus Anticoagulant (LA) disorder in clinical chemistry evaluations.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "in-vitro diagnostic product" and describes "reagents" and their chemical properties and interactions, indicating a physical component is central to its function.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use/Indications for Use: The very first sentence explicitly states: "The HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays are qualitative in-vitro diagnostic products..." This directly identifies the device as an IVD.
• Intended User/Care Setting: It states "For in-vitro diagnostic use only." This further reinforces its classification as an IVD.
• Device Description: The description details how the assays are used to analyze human citrated plasma to aid in the detection of lupus anticoagulants, which is a diagnostic process performed outside of the body (in vitro).
• Performance Studies: The document describes various performance studies (Precision/Reproducibility, Analytical specificity, Comparison studies, Matrix Comparison, Expected values/Reference range) which are typical evaluations for IVD devices to demonstrate their analytical and clinical performance.
• Key Metrics: The mention of "Positive Percent Agreement (PPA)" and "Negative Percent Agreement (NPA)" are common metrics used to evaluate the performance of diagnostic tests.

All of these points clearly indicate that the HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays are intended for use in a laboratory setting to diagnose a condition by analyzing a sample taken from a patient, which is the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays are qualitative in-vitro diagnostic products to aid in the detection of lupus anticoagulants in human citrated plasma by the diluted Russell's Viper Venom method, on the ACL TOP® Family. The HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays are intended to evaluate patients who have unexplained prolonged APTT test results The HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays should be used in parallel as an integrated test for Lupus Anticoagulant detection.

Product codes (comma separated list FDA assigned to the subject device)

GIR

Device Description

DRVVT Screen and dRVVT Confirm are improved dRVVT reagents, intended to simplify and standardize the detection of Lupus Anticoagulant (LA) disorder in clinical chemistry evaluations. DRVVT Screen is poor in phospholipid, making it sensitive to LA. The additional amount of phospholipid in dRVVT Confirm neutralizes LA to give shorter clotting times.

Russell's viper venom, in the presence of calcium, directly activates factor X (in a test sample). DRVVT Screen and dRVVT Confirm are therefore unaffected by contact factor abnormalities, factor VII, VIII and IX deficiencies, or inhibitors. As a result, dRVVT Screen and dRVVT Confirm are more specific tests for the evaluation of LA than APTT.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

• Precision/Reproducibility: Precision was assessed utilizing 3 lots of reagent on 3 representative members of the ACL TOP Family (ACL TOP and ACL TOP 500 CTS) by 3 independent operators. Precision was evaluated in accordance with CLSI EP05-A213, for 20 days, with 2 runs per day and 2 replicates per run for each sample level (n=80/ instrument/ lot).
  • Key results: Total (%CV) for LA Negative Control ranged from 2.1 to 3.4, for Weakly LA Positive Control ranged from 2.2 to 3.0, and for LA Positive Control ranged from 3.0 to 5.0.
• Analytical specificity (Interference studies): Conducted on a representative member of the ACL TOP Family by spiking different concentrations of interferents into pooled normal plasma, weak LA Positive plasma, and high LA Positive plasma.
  • Maximum tolerated concentrations not causing interference: Unfractionated Heparin (UFH) ≤ 1.0 IU/mL, Low Molecular Weight Heparin (LMWH) ≤ 1.0 IU/m, Hemoglobin ≤ 200 mg/dL, Bilirubin ≤ 10 mg/dL, Triglyceride ≤ 500 mg/dL.
• Assay cut-off: The Normalized Ratio cut off was determined using 40 normal healthy individual samples and calculating the Mean + 3SD.
  • Key results: ACL TOP and ACL TOP 500CTS had a Normalized dRVVT Ratio Cut Off of >1.2.
• Comparison studies (in-house method comparison): Performed in accordance with EP09-A244, on 115 samples (80 Normal / 35 known LA Positive), on a representative member of the ACL TOP Family (ACL TOP Base & ACL TOP 500 CTS).
  • Key results:
    • ACL TOP: PPA 100.0% (35/35), NPA 100.0% (80/80), Overall 100% (115/115).
    • ACL TOP 500 CTS: PPA 100.0% (35/35), NPA 100.0% (80/80), Overall 100% (115/115).
• Comparison studies (US field sites validation): Results subsequently validated by 3 US field sites. Each site established its own cut-off, and validated that cut-off with 100+ samples.
  • Key results:
    • Site 1: PPA 92.7% (38/41), NPA 98.9% (91/92), Overall 97% (129/133).
    • Site 2: PPA 90.2% (46/51), NPA 98.9% (91/92), Overall 95.8% (137/143).
    • Site 3: PPA 98.1% (52/53), NPA 100.0% (80/80), Overall 99.2% (132/133).
• Matrix Comparison (Citrate study): Performed to assess the effect on the assays of collecting blood samples in 3.8% versus 3.2% sodium citrate sample tubes. Plasma from 26 donors was collected in parallel in both tube types. Artificial LA-Positive samples were prepared.
  • Key results: dRVVT Normalized Ratio on the ACL TOP is not affected by the type of citrate tubes used. PPA 19/19 (100%), NPA 24/26 (92%).
• Matrix Comparison (Fresh v. Frozen study): Conducted to demonstrate that the results of fresh and frozen and once thawed samples are equivalent. Blood samples drawn from 26 normal healthy donors. LA-Positive samples were prepared.
  • Key results: dRVVT Normalized Ratio on the ACL TOP Family is not affected by whether the analysis is performed on fresh or frozen samples. PPA 28/28 (100%), NPA 26/26 (100%).
• Expected values/Reference range: A normal range study (n=120) was performed in accordance with CLSI C28-A32 using dRVVT Screen/dRVVT Confirm on representative members of the ACL TOP Family.
  • Key results:
    • ACL TOP: Lower Limit 0.92 (0.91-0.93), Upper Limit 1.11 (1.10-1.15).
    • ACL TOP 500 CTS: Lower Limit 0.91 (0.89-0.92), Upper Limit 1.13 (1.11-1.16).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

• Positive Percent Agreement (PPA)
• Negative Percent Agreement (NPA)
• Total (%CV)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K990302

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 864.8950 Russell viper venom reagent.

(a)
Identification. Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.(b)
Classification. Class I (general controls).

Summary

0

510K SUMMARY

A.		510(k) Number	K110031	AUG 2 4 2011
B.		Purpose for
Submission	New product
D.		Measurand	Lupus anticoagulant
F.		Type of Test	Diluted Russell's venom clotting assay
H.		Applicant	Instrumentation Laboratory Co.
J.		Proprietary &
Established
Names	HemosIL® dRVVT Screen and HemosIL dRVVT Confirm Assays
L.	Regulatory Information
	1.	Regulation section:	21CFR §864.8950, Russell's viper venom reagent
	2.	Classification:	Class II
	3.	Product code:	GIR
	4.	Device classification name:	Reagent, Russell's Viper Venom

Intended Use H.

• Intended use(s): 1.
  The HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays are qualitative in-vitro diagnostic products to aid in the detection of lupus anticoagulants in human citrated plasma by the diluted Russell's Viper Venom method, on the ACL TOP® Family. The HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays are intended to evaluate patients who have unexplained prolonged APTT test results The HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays should be used in parallel as an integrated test for Lupus Anticoagulant detection.

• Indication(s) for use: 2.
  Same

Special conditions for use statement(s):

For in-vitro diagnostic use only. For prescription use. HemosIL dRVVT Confirm is intended to be used in conjunction with HemosIL dRVVT Screen.

• 3. Special instrument requirements:
     ACL TOP Family Analyzers

1

Device Description

DRVVT Screen and dRVVT Confirm are improved dRVVT reagents, intended to simplify and standardize the detection of Lupus Anticoagulant (LA) disorder in clinical chemistry evaluations. DRVVT Screen is poor in phospholipid, making it sensitive to LA. The additional amount of phospholipid in dRVVT Confirm neutralizes LA to give shorter clotting times.

Russell's viper venom, in the presence of calcium, directly activates factor X (in a test sample). DRVVT Screen and dRVVT Confirm are therefore unaffected by contact factor abnormalities, factor VII, VIII and IX deficiencies, or inhibitors. As a result, dRVVT Screen and dRVVT Confirm are more specific tests for the evaluation of LA than APTT.

Substantial Equivalence Information J.

• Predicate device name(s): HemosIL LAC Screen & LAC Confirm (self) 1.
• Predicate 510(k) number(s): K990302 2.
• Comparison with predicate: 3.

Similarities

The applicants, HemosIL dRVVT Screen and HemosIL dRVVT Confirm (PNs 000200301500 & 00020301600 respectively) are Substantially Equivalent to their predicates, the HemosIL LAC Screen and HemosIL LAC Confirm (K990302).

	Table of similarities:

Item	Predicate Device	Applicant
Device Name	HemosIL LAC Screen & LAC
Confirm	HemosIL dRVVT Screen & dRVVT
Confirm
K#	K990302	K110031
Indications
for Use	HemosiL LAC Screen and HemosIL
LAC Confirm are in vitro diagnostic
products for the detection of lupus
anticoagulants (a type of
phospholipid interfering antibody)
in human citrated plasma on the
ACL TOP Family.	The HemosIL dRVVT Screen and
HemosIL dRVVT Confirm assays
are qualitative in-vitro diagnostic
products to aid in the detection of
lupus anticoagulants in human
citrated plasma by the diluted
Russell's Viper Venom method, on
the ACL TOP® Family. The HemosIL
dRVVT Screen and HemosIL dRVVT
Confirm assays are intended to
evaluate patients who have
unexplained prolonged APTT test
results The HemosIL dRVVT
Screen and HemosIL dRVVT
Confirm assays should be used in
parallel as an integrated test for
Lupus Anticoagulant detection.
Sample Type	Citrated plasma	Same

• l.

2

Item	Predicate Device	Applicant
Reagent
composition	Russell's viper venom,
phospholipids, calcium and heparin
inhibitor	Same
Test Principle	LAC Screen and LAC Confirm are
improved dRVVT reagents,
intended to simplify and
standardize the detection of Lupus
Anticoagulant (LA) disorder in
clinical chemistry evaluations. LAC
Screen is poor in phospholipid,
making it sensitive to LA. The
additional amount of phospholipid
in LAC Confirm neutralizes LA to
give shorter clotting times.
Russell's viper venom, in the
presence of calcium, directly
activates factor X (in a test sample).	Same

Differences

The main difference between the applicant, HemosIL dRVVT Screen and dRVVT Confirm, and their predicates HemosIL LAC Screen and LAC Confirm, is that the applicants have improved stability as compared to their predicates.

Standard/Guidance Document Referenced (if applicable) K.

No performance standard or FDA guidance has been established for these reagents.

L. Test Principle

In dRVVT screening assays, a low, rate-limiting concentration of phospholipid is used to give a clotting time which is sensitive to the presence of lupus anticoagulants, since anti-phospholipid antibodies interfere with the clot-promoting role of phospholipid in vitro. A prolonged clotting time of a patient sample that does not correct with the addition of an equal volume of normal plasma suggests the presence of a lupus anticoagulant.

An abnormal result for the initial dRVVT screening assay should be followed by a dRVVT confirmatory test. In this test, the inhibitory effect of lupus anticoagulants on phospholipids in the dRVVT can be overcome by adding an excess of phospholipid to the assay.

The clotting times of both the initial dRVVT assay and confirmatory test are subsequently normalized and then used to determine a ratio: the time without phospholipid excess to time with phospholipid excess, the so called "normalized ratio". A ratio greater than the laboratory established cut-off is considered a positive result and implies that the patient may have anti-phospholipid antibodies.

3

Performance Characteristics

• Analytical performance 1.
  • Precision/Reproducibility a.

Precision was assessed utilizing 3 lots of reagent on 3 representative members of the ACL TOP Family (ACL TOP and ACL TOP 500 CTS) by 3 independent operators. Precision was evaluated in accordance with CLSI EP05-A213, for 20 days, with 2 runs per day and 2 replicates per run for each sample level (n=80/ instrument/ lot), with the following results:

ACL TOP Family	dRVVT NR
LA Negative Control	1.00
Weakly LA Positive Control	1.35
LA Positive Control	1.77

HemosIL dRVVT NR	Within Run (%CV)			Between Run (%CV)			Total (%CV)
	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3	Lot 1	Lot 2	Lot 3
LA Negative Control	1.2	2.0	0.8	1.7	2.8	1.9	2.3	3.4	2.1
Weakly LA Positive	1.1	0.9	0.6	2.7	2.1	2.0	3.0	2.6	2.2
LA Positive Control	1.5	0.9	1.1	4.4	3.4	2.5	5.0	3.5	3.0

• Linearity/assay reportable range: NA, qualitative assay. b.
• C. Traceability, Stability, Expected values (controls, calibrators, or methods):

Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C. Stability after reconstitution: 15 days at 2-8°C in the closed original vial or 3 days at 15°C in the original vials on the ACL TOP Family. dRVVT Screen/ Confirm may be used with either fresh or frozen samples. For optimal stability remove reagents from the system and store them, closed, at 2-8°C, in their original vials. Based on the results of the accelerated stability study, a shelf-life of at least 2 years is claimed for the products when stored at 2- 8°C. Real-time stability testing is ongoing, and will be used to update the shelf life as more data becomes available.

• Detection limit: NA d.
• Analytical specificity: e.

Interference studies were conducted on a representative member of the ACL TOP Family. Different concentrations of interferent were spiked into pooled normal plasma, weak LA Positive plasma and high LA Positive plasma The maximum concentration tolerated in the assay was defined as the highest concentration of interferent relative to the recovered value of the base clotting time ± 15%. The maximum tolerated concentrations not causing interference at any LA level tested were:

Possible Interferant	Not affected by concentrations
Unfractionated Heparin (UFH)	≤ 1.0 IU/mL
Low Molecular Weight Heparin (LMWH)	≤ 1.0 IU/m
Hemoglobin	≤ 200 mg/dL
Bilirubin	≤ 10 mg/dL
Triglyceride	≤ 500 mg/dL

M.

4

Normalized dRVVT ratio higher than the internal-study cut-off (NR > 1.2) was found in the following plasma samples using dRVVT Screen/dRVVVT Confirm:

Sample	ACL TOP Base	ACL TOP 500CTS
Known LA Positive	100% (35/35)	100% (35/35)
Oral Anticoagulants	40% (2/5)	40% (2/5)
LMWH	0% (0/5)	0% (0/5)
UFH	20% (1/5)	0% (0/5)
DIC	0% (0/5)	0% (0/5)
Factor Deficiency	0% (0/6)	0% (0/6)

f. Assay cut-off:

The Normalized Ratio cut off was determined as recommended using 40 normal healthy individual samples and calculating the Mean + 3SD. The results were obtained using a specific lot of reagent. Due to many variables which may affect results, each laboratory should establish its own NR cut off.

System	Normalized dRVVT Ratio Cut Off
ACL TOP	>1.2
ACL TOP 500CTS	>1.2

Comparison studies: 2.

• a. An in-house method comparison was performed in accordance with EP09-A244, on 115 samples (80 Normal/ 35 known LA Positive), on a representative member of the ACL TOP Family (ACL TOP Base & ACL TOP 500 CTS). The Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) were calculated with the following result(s):

| Cut-Off
(Mean+3SD) | LAC
NR | dRVVT
NR | PPA | CI 95% | NPA | CI 95% | Overall | Reference |
|-----------------------|-----------|-------------|-------------------|-------------|-------------------|-------------|-------------------|------------------------|
| ACL TOP | > 1.2 | > 1.2 | 100.0%
(35/35) | 90.1-100.0% | 100.0%
(80/80) | 95.4-100.0% | 100%
(115/115) | LAC Screen/
Confirm |
| ACL TOP
500 CTS | > 1.2 | > 1.2 | 100.0%
(35/35) | 90.1-100.0% | 100.0%
(80/80) | 95.4-100.0% | 100%
(115/115) | |

Results were subsequently validated by 3 US field sites. Each site established its own cut-off, and validated that cut-off with 100+ samples, with the following result(s):

| Cut-Off
(Mean+3SD) | LAC
NR | dRVVT
NR | PPA | CI 95% | NPA | CI 95% | Overall | Reference |
|-----------------------|-----------|-------------|------------------|------------|-------------------|-------------|--------------------|------------------------|
| Site 1 | > 1.2 | > 1.2 | 92.7%
(38/41) | 80.6-97.5% | 98.9%
(91/92) | 94.1- 99.8% | 97%
(129/133) | LAC Screen,
Confirm |
| Site 2 | > 1.3 | > 1.3 | 90.2%
(46/51) | 79.0-95.7% | 98.9%
(91/92) | 94.1- 99.8% | 95.8%
137/143 | |
| Site 3 | > 1.3 | > 1.2 | 98.1%
(52/53) | 90.1-99.7% | 100.0%
(80/80) | 95.4-100.0% | 99.2%
(132/133) | |

5

Matrix Comparison b.

A citrate study was performed to assess the effect on the assays of collecting the blood samples in 3.8% versus 3.2% sodium citrate sample tubes. Plasma from 26 donors was collected, in parallel, in both tube types. Artificial LA-Positive samples were prepared by spiking with different amounts of B2gPl antibodies to produce a range of concentrations. Using the previously established cut-off, the dRVVT Normalized Ratios for both 3.8% and 3.2% sodium citrate sample tubes were calculated. The two NRs were compared for their Positive and Negative Percent Agreement.

Results showed that the dRVVT Normalized Ratio on the ACL TOP is not affected by the type of citrate tubes used to draw blood samples.

3.8 v. 3.2% Na Citrate	PPA	CI 95%	NPA	CI 95%
ACL TOP	19/19 (100%)	83.2-100%	24/26 (92%)	75.9-97.9%

A fresh v. frozen study was conducted to demonstrate that the results of fresh and frozen and once thawed samples are equivalent. Blood samples were drawn from 26 normal healthy donors. LA-Positive samples were prepared by spiking this pool with different amounts of ß2gPl antibodies. Fresh samples were kept at room temperature. Frozen samples were stored at -65℃ for 24 hr, prior to being thawed and analyzed at room temperature. Using the previously established cut-off, the dRVVT Normalized Ratios for both fresh and frozen (normal and LA-antibodies-spiked) samples were calculated. The two NRs were compared for their Positive and Negative Percent Agreement. The method comparison demonstrated that the dRVVT Normalized Ratio on the ACL TOP Family is not affected by whether the analysis is performed on fresh or frozen samples.

Fresh vs. Frozen	PPA	CI 95%	NPA	CI 95%
ACL TOP	28/28 (100%)	87.9%-100%	26/26 (100%)	87.1%-100%

• 3. Clinical Studies:
  • a. Clinical Sensitivity: NA
  • b. Clinical Specificity: NA
  • C. Other clinical supportive data (when a. and b. are not applicable): NA
• Clinical cut-off: NA 4.
• 5. Expected values/Reference range:

A normal range study (n=120) was performed, in accordance with CLSI C28-A32, using dRVVT Screen/dRVVT Confirm on representative members of the ACL TOP Family. The following Reference intervals were established for dRVVT Screen, and for the dRVVT Screen/ Confirm Normal Ration (NR):

	Normal Ratio Reference Interval (NR)
System	Lower Limit	Upper Limit
ACL TOP	0.92 (0.91-0.93)	1.11 (1.10-1.15)
ACL TOP 500 CTS	0.91 (0.89-0.92)	1.13 (1.11-1.16)

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N. Proposed Labeling

The labeling is sufficient and 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.

P. Administrative Information

Applicant Contact Information

Name of applicant:	Instrumentation Laboratory Co.
Mailing address:	180 Hartwell Road
Bedford, MA 01730, USA
Phone #:	781-861-4350
Fax #:	781-861-4207
E-mail address:	[e-mail]
Contact:	Jacqueline Emery, BSEE
Regulatory Affairs Manager
Date Prepared	July 30, 2011

Reference(s):

• 1. CLSI C28-A3: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, 30 edition.
• 2. Pengo V et al. Update of the Guidelines for Lupus Anticoagulant Detection. J. Thromb. Haem. 2009; 7:1737-1740.
• 3. Clinical and Laboratory Standards/CLSI. Establishment of Quantitative Measurement Procedures; Approved Guideline. Document EP5-A3: Vol. 0 No. 0.
• 4. Clinical and Laboratory Standards/CLSI. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. Document EP9-A2: Vol. 22 No.19.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure, represented by flowing lines, with its arms outstretched.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Instrumentation Laboratory Co. c/o Ms. Jacqueline Emery Regulatory Affairs Manager 180 Hartwell Road Bedford. MA 01730

AUG 2 4 2011

Re: K110031

Trade/Device Name: HemosIL® dRVVT Screen and dRVVT Confirm Regulation Number: 21 CFR 864.8950 Regulation Name: Russell Viper Venom Test Regulatory Class: Class II Product Code: GIR, GGC Dated: August 16, 2011 Received: August 19, 2011

Dear Ms. Emery:

(

We have reviewed your Section 510(k) premarket notification of intent to market the device w & nave and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, do nots may been revire approval of a premarket approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, additional come of Enting may 2007 - 10 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I toase of a rised a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must of any I out all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

8

Page 2 - Ms. Jacqueline Emery

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirents as set form in the quality of think (